beta-alanine and Apoplexy

beta-alanine has been researched along with Apoplexy in 386 studies

Research

Studies (386)

Authors

Clinical Trials (29)

Trial Overview

Trial Outcomes

Abnormal Liver Function Test

Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST>3xULN and total bilirubin > 2 x ULN (NCT00262600)
Timeframe: 36 months

Yearly Event Rate for Composite Endpoint of Stroke/SEE

Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 (NCT00262600)
Timeframe: 36 months

Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death

Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 (NCT00262600)
Timeframe: 36 months

Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death

Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 (NCT00262600)
Timeframe: 36 months

Bleeding Events (Major and Minor)

"Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25~Major bleeds are adjudicated, whereas minor bleeds are investigator reported." (NCT00262600)
Timeframe: 36 months

Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)

Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH) (NCT00262600)
Timeframe: 36 months

Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy." (NCT00808067)
Timeframe: up to 43 months

Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)

Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. (NCT00808067)
Timeframe: up to 43 months

Annualized Rate of Subjects With Minor Bleeds

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not." (NCT00808067)
Timeframe: up to 43 months

Death, Annualized Rate of Subject Death

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology." (NCT00808067)
Timeframe: up to 43 months

Deep Vein Thrombosis, Annualized Rate of Subjects With DVT

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Deep Vein Thrombosis (DVT) was generally documented by one of the following:~abnormal compression ultrasound (CUS),~an intraluminal filling defect on venography." (NCT00808067)
Timeframe: up to 43 months

Major Bleeding, Annualized Rate of Subjects With Major Bleeds

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Major bleeding must have satisfied one or more of the following criteria:~Bleeding associated with a reduction in hemoglobin of at least 20 g/L~Required transfusion of at least 2 units of blood or packed cells~Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal~Major bleed were classified as life-threatening if they met one or more of the following criteria:~Reduction in hemoglobin of at least 50 g/L~Transfusion of at least 4 units of blood or packed cells~Symptomatic intracranial bleeding, either subdural or intracerebral~Associated with hypotension requiring use of intravenous inotropic agents~Required surgical intervention to stop bleeding~Resulted in death" (NCT00808067)
Timeframe: up to 43 months

Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy." (NCT00808067)
Timeframe: up to 43 months

Pulmonary Embolism (PE), Annualized Rate of Subjects With PE

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Pulmonary Embolism was generally documented by one of the following:~an intraluminal filling defect in segmental or more proximal branches on spiral CT scan~an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram~a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)~inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography." (NCT00808067)
Timeframe: up to 43 months

Stroke, Annualized Rate of Subjects With Stroke

"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital" (NCT00808067)
Timeframe: up to 43 months

Percentage of Patients With AEs Leading to Discontinuation of Trial Drug

"Percentage of patients with Adverse Events leading to discontinuation of trial drug.~Prespecified clinical outcome events were not recorded as Adverse Events." (NCT01505881)
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Percentage of Patients With Any Adverse Event (AE)

Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events. (NCT01505881)
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Percentage of Patients With Serious AEs

Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events. (NCT01505881)
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.

"Clinical efficacy outcome events presented are:~Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis" (NCT01505881)
Timeframe: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)

Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12

"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~(As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients)~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population." (NCT01452347)
Timeframe: Week 12

Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2

"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population." (NCT01452347)
Timeframe: Week 2

Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4

"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population." (NCT01452347)
Timeframe: Week 4

Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1

"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) .~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population." (NCT01452347)
Timeframe: Week 1

Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12

Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group. (NCT01452347)
Timeframe: Week 12

Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1

Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. (NCT01452347)
Timeframe: Week 1

Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2

Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. (NCT01452347)
Timeframe: Week 2

Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4

Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group. (NCT01452347)
Timeframe: Week 4

Age Group

(NCT01428765)
Timeframe: Baseline

Antithrombotic Treatment Choice at Baseline

(NCT01428765)
Timeframe: Baseline

CHA2DS2-VASc Score

"The CHA2DS2-VASc risk score is based on a point system in which 2 points are assigned for a history of stroke or TIA, or age ≥75; and 1 point each is assigned for age 65-74 years, a hypertension, diabetes, cardiac failure, vascular disease and female sex. On the basis of the risk strata defined in previous guidelines, a CHA2DS2-VASc score of 0 corresponds to low risk, a score of 1 corresponds to intermediate risk, and a score of 2 or more corresponds to high risk." (NCT01428765)
Timeframe: Baseline

CHADS2 Score

CHADS2 score is based on a point system in which 2 points are assigned for a history of stroke or transient ischemic attack and 1 point each is assigned for age equal to or greater more than 75 years, hypertension, diabetes, or clinical heart failure or impaired left ventricular systolic function (generally interpreted as an ejection fraction ≤ 40%). (NCT01428765)
Timeframe: Baseline

Concomitant Medication

(NCT01428765)
Timeframe: Baseline

Gender

(NCT01428765)
Timeframe: Baseline

HAS-BLED Risk Score

The HAS-BLED score is based on a point system in which 1 point is assigned for hypertension (systolic blood pressure >160 mmHg), 1 point for each of abnormal renal (presence of chronic dialysis or renal transplantation or serum creatinine ≥200 μmol/L) and liver (chronic hepatic disease or biochemical evidence of significant hepatic derangement) function, 1 point each is assigned for stroke, bleeding (previous bleeding history and/or predisposition to bleeding), labile Internation Normalized Ratios (INRs,unstable/high INRs or poor time in therapeutic range), age >65 years and 1 point each for drugs (such as antiplatelet agents, non-steroidal anti-inflammatory drugs) or alcohol. (NCT01428765)
Timeframe: Baseline

Medical History

(NCT01428765)
Timeframe: Baseline

Incidence Rate of All-cause Death

Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death)

Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Life-threatening Bleeding Events

Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Major Bleeding Events

Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Myocardial Infarction

Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Pulmonary Embolism (PE)

Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Stroke

Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Stroke or Systemic Embolism

Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Systemic Embolism (SEE)

Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Transient Ischaemic Attack (TIA)

Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death)

Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Vascular Death

Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. (NCT01671007)
Timeframe: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of All-cause Death - Phase II

Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of All-cause Death - Phase III

Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II

Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III

Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Life-threatening Bleeding Events - Phase II

Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of Life-threatening Bleeding Events - Phase III

Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Major Bleeding Events (MBE) - Phase II

Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of Major Bleeding Events (MBE) - Phase III

Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Myocardial Infarction (MI) - Phase II

Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of Myocardial Infarction (MI) - Phase III

Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Pulmonary Embolism (PE) - Phase II

Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of Pulmonary Embolism (PE) - Phase III

Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Stroke - Phase II

Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of Stroke - Phase III

Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Stroke or Systemic Embolism - Phase III

Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Systemic Embolism (SE) - Phase II

Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of Systemic Embolism (SE) - Phase III

Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II

Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III

Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II

Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III

Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Incidence Rate of Vascular Death - Phase II

Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. (NCT01468701)
Timeframe: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.

Incidence Rate of Vascular Death - Phase III

Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. (NCT01468701)
Timeframe: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban

The investigators will calculate the # of gap days between refills for dabigatran/rivaroxaban/apixaban for each3 and 6 months of the pilot intervention. This will be based on pharmacy refill data and calculated using the date dabigatran/rivaroxaban/apixaban was dispensed and the # of days supplied for that prescription. We will add the # of gap days for each 3 and 6 months of the pilot for each patient, and compare the total # of gaps days between intervention and usual care patients. The gap days between refills is a validated measure of adherence and identifies patients with sub-optimal adherence.A negative gap day value indicates that participants received the refill prior to completion of the previous prescription. (NCT01578044)
Timeframe: 3 and 6 months

Apixaban Plasma Concentration, Cmax

Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose

Apixaban Plasma Concentration, Cmin

Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose

Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12)

Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0 to 12 hours after dose was given on Day 1. (NCT02942407)
Timeframe: 0-12 hours post-dose

Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding

"Assess the safety of apixaban versus warfarin regarding ISTH major bleeding or clinically relevant non-major bleeding events in patients with NVAF (nonvalvular atrial fibrillation) and ESRD (end-stage renal disease) on hemodialysis.~Major bleeding event is defined as:Acute clinically overt bleeding (including access site related bleeding) accompanied by 1 or more of the following: Decrease in Hgb of 2g/dL or more with overt bleeding; Transfusion of 2 or more units of packed RBCs in the setting of an overt bleeding event; Bleeding within a critical site. Hemorrhagic stroke (primary or infarction with hemorrhagic conversion) were classified as major bleeds.~Non-major bleeding event is defined as: Acute or sub-acute clinically overt bleeding (including access site related bleeding) that does not meet criteria for major bleeding & results in Hospital admission for bleeding, physician guided medical or surgical treatment for bleeding, or change in antithrombotic therapy" (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Number of Participants Experiencing Mortality

Evaluate mortality rates for those participants randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Number of Participants Experiencing Stroke

"Adjudcated stroke defined as a new, non-traumatic episode of focal or global neurological dysfunction of sudden onset caused by central nervous system (CNS) vascular injury as a result of hemorrhage or infarction and not due to a readily identifiable non-vascular cause (i.e. brain tumor). CNS includes brain, spinal cord and retina. The required duration of the deficit is ≥ 24 hours.~Events with neurologic deficit lasting for < 24 hours and an imaging modality showing evidence of an acute stroke will be counted as stroke as well.~A retinal ischemic event (embolism, infarction) will be considered a stroke" (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Number of Participants Experiencing Stroke or Systemic Embolism

Number of participants experiencing adjudicated stroke or systemic embolism. (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Number of Participants Experiencing Stroke, Systemic Embolism, Major Bleeding or All-cause Mortality

"Evaluate those experiencing stroke, systemic embolism, ISTH major bleeding, or all-cause mortality for those randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis~Definitions of stroke and systemic embolism are provided under the measurement description of the secondary outcomes for each individual event. Definition of major bleed is provided in outcome measurement description of the primary outcome measure." (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Number of Participants Experiencing Systemic Embolism

"Adjudicated diagnosis of systemic arterial embolism (Non-pulmonary, non-cranial events) will require a positive clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which is supported by evidence of embolism/thrombosis from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.~Clinical presentation would include:~Abrupt development of pain, absent pulses, pallor, and/or paresis in an extremity (at least an entire digit) without previous severe claudication or findings of severe peripheral vascular disease.~Renal embolism will be diagnosed when sudden flank pain or a change in renal laboratory findings occurred.~Abdominal vascular/visceral embolism was considered definite if acute abdominal symptoms or referred symptoms developed along with a change in abdominal examination or appropriate laboratory values." (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Persistence of Therapy

Evaluate days between time from initiation to discontinuation of randomized therapy. (NCT02942407)
Timeframe: Randomization up to Month 15/Final Visit

Reviews

135 reviews available for beta-alanine and Apoplexy

Trials

12 trials available for beta-alanine and Apoplexy