aspirin and Cardio-embolic Stroke

aspirin has been researched along with Cardio-embolic Stroke in 16 studies

Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.
acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity.

Research

Studies (16)

Authors

Clinical Trials (6)

Trial Overview

Trial Outcomes

Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death

Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period. (NCT02239120)
Timeframe: From randomisation until full follow up period, up to 43 months

Adjudicated Fatal Bleed

Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated. (NCT02239120)
Timeframe: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Adjudicated Intracranial Hemorrhage

"Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic.~The annualised event rate represents the average number of events per patient during a 1-year period." (NCT02239120)
Timeframe: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Adjudicated Ischaemic Stroke

Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period. (NCT02239120)
Timeframe: From randomisation until full follow up period, up to 43 months

Adjudicated Life-threatening Bleed

"Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention.~The annualised event rate represents the average number of events per patient during a 1-year period." (NCT02239120)
Timeframe: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Adjudicated Recurrent Stroke

Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period. (NCT02239120)
Timeframe: From randomisation until full follow up period, approximately 43 months.

All-cause Death

All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period. (NCT02239120)
Timeframe: From randomisation until full follow up period, up to 43 months

Any Bleed (Investigator-reported)

"This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity.~The annualised event rate represents the average number of events per patient during a 1-year period." (NCT02239120)
Timeframe: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Disabling Stroke

Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period. (NCT02239120)
Timeframe: From randomisation until full follow up period, up to 43 months

First Major Bleed (Adjudicated)

"First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows:~Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or,~Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of ≥2 units of blood or packed cells (equivalent to ≥4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or,~Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period." (NCT02239120)
Timeframe: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)

Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (>=) 2 grams per decilitre (g/dL) (20 grams per liter [g/L]; 1.24 millimoles per liter [mmol/L]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of All-Cause Mortality

All-cause mortality includes all deaths of participants due to any cause. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction

Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. Cardiovascular death includes death due to hemorrhage and death with undetermined/unknown cause. Systemic embolism is defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms. The diagnosis of myocardial infarction requires the combination of: 1)evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and 2)supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of Clinically Relevant Non-Major Bleeding Events

Non-major clinically relevant bleeding was defined as non-major overt bleeding but required medical attention (example: hospitalization, medical treatment for bleeding), and/or was associated with the study drug interruption of more than 14 days. The results were based on the outcome events at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of Intracranial Hemorrhage

Intracranial hemorrhage included all bleeding events that occurred in intracerebral, sub arachnoidal as well as subdural or epidural sites. The below table displays results for all randomized participants and the outcomes at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of Life-Threatening Bleeding Events

Life-threatening bleeding was defined as a subset of major bleeding that met at least one of the following criteria: 1) fatal bleeding; 2) symptomatic intracranial haemorrhage; 3) reduction in hemoglobin of at least 5 g/dl (50 g/l; 3.10 mmol/L); 4) transfusion of at least 4 units of packed red cells or whole blood; 5) associated with hypotension requiring the use of intravenous inotropic agents; 6) necessitated surgical intervention. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of the Composite Efficacy Outcome (Adjudicated)

Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction

"Disabling stroke is defined as stroke with modified Rankin score (mRS) greater than or equal to (>=) 4 as assessed by investigator. mRS spans 0-6, running from perfect health to death. A score of 0-3 indicates functional status ranging from no symptoms to moderate disability (defined in the mRS as requiring some help, but able to walk without assistance); mRS 4-6 indicates functional status ranging from moderately severe disability (unable to walk or to attend to own bodily needs without assistance)through to death. CV death includes death due to hemorrhage and death with undetermined/unknown cause. Diagnosis of myocardial infarction requires combination of: 1) evidence of myocardial necrosis either changes in cardiac biomarkers or post-mortem pathological findings); 2) supporting information derived from clinical presentation, electrocardiographic changes, or results of myocardial or coronary artery imaging." (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage

Secondary efficacy outcome: Number of participants with ischemic stroke, myocardial infarction, death from ischemic vascular causes, or major hemorrhage (NCT00991029)
Timeframe: Up to 90 days

Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes

Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (NCT00991029)
Timeframe: Up to 90 days

Death From Any Cause

Other safety outcome: Number of Participants with Death from any cause (NCT00991029)
Timeframe: up to 90 days

Death From Ischemic Vascular Causes

Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes (NCT00991029)
Timeframe: Up to 90 days

Hemorrhagic Stroke

Other safety outcome: Number of participants with Hemorrhagic stroke (NCT00991029)
Timeframe: up to 90 days

Ischemic or Hemorrhagic Stroke

Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke (NCT00991029)
Timeframe: Up to 90 days

Ischemic Stroke

Secondary efficacy outcome:Number of participants with Ischemic stroke (NCT00991029)
Timeframe: Up to 90 days

Major Hemorrhage

Primary safety outcome: Number of Participants with major hemorrhage (NCT00991029)
Timeframe: Up to 90 days

Major Hemorrhage Other Than Intracranial Hemorrhage

Other safety outcome: Number of Participants with Major hemorrhage other than intracranial hemorrhage (NCT00991029)
Timeframe: up to 90 days

Minor Hemorrhage

Other safety outcome:Number of Participants with Minor hemorrhage (NCT00991029)
Timeframe: up to 90 days

Myocardial Infarction

Secondary efficacy outcome: Number of participants with Myocardial infarction (NCT00991029)
Timeframe: Up to 90 days

Other Symptomatic Intracranial Hemorrhage

Other safety outcome: Number of participants with other symptomatic intracranial hemorrhage (NCT00991029)
Timeframe: up to 90 days

Symptomatic Intracerebral Hemorrhage

Other safety outcome: Number of participants with Symptomatic intracerebral hemorrhage (NCT00991029)
Timeframe: up to 90 days

EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit

"EQ-5D index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1." (NCT01994720)
Timeframe: End of treatment visit (Day 90+-7d)

EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit

"EQ-5D index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1." (NCT01994720)
Timeframe: Premature treatment discontinuation visit(<15 days after last dose)

EQ-5D at Visit 1 (Enrolment)

"EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1." (NCT01994720)
Timeframe: Visit 1 (Enrolment)

EQ-5D at Visit 2 (Day 7+-2d)

"EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1." (NCT01994720)
Timeframe: Visit 2 (Day 7+-2d)

Net Clinical Outcome

Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants by Severity of Stroke and Overall Disability

"Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS.~Modified Rankin Score:~0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead.~Disability defined as mRS > 1.~Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables." (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants With All-Cause Death

Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants With Composite of Ischaemic Stroke, MI and CV Death

Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants With Composite of Stroke/MI/Death

Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants With CV Death

Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants With Disabling Stroke

Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants With Fatal Stroke

Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants With Ischaemic Stroke

Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants With MI

Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97) (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants With PLATO Major Bleeding Event

"Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).~PLATO Major bleeding is defined as a bleed that is any one of:~Fatal~Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI)~Intrapericardial bleed with cardiac tamponade~Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery~Significantly disabling (eg. intraocular with permanent vision loss)~Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L)~Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding." (NCT01994720)
Timeframe: From randomization up to 97 days

Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event

Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). (NCT01994720)
Timeframe: Time from first dose and up to and including 7 days following the date of last dose of the study

Number of Participants With Stroke

Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97) (NCT01994720)
Timeframe: From randomization up to 97 days

Change in NIHSS

"Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale):~0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke." (NCT01994720)
Timeframe: From randomization up to 97 days

AF Detection Rate Within 12 Months

Percentage of subjects with AF detected within 12 months of follow-up (NCT00924638)
Timeframe: 12 months

AF Detection Rate Within 6 Months

Percentage of subjects with AF detected within 6 months of follow-up (NCT00924638)
Timeframe: 6 months

Clinical Disease Burden and Care Pathway

Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months (NCT00924638)
Timeframe: 12 months

Health Outcome as Evaluated by EQ-5D Questionnaire

EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health). (NCT00924638)
Timeframe: 12 months

Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)

Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up (NCT00924638)
Timeframe: 12 months

Use of Antiarrhythmic Drugs

Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit (NCT00924638)
Timeframe: 12 months

Use of Oral Anticoagulation (OAC) Drugs

Percentage of subjects who were using OAC drugs at the 12 months follow-up visit (NCT00924638)
Timeframe: 12 months

Impact of Patient Assistant Use on AF Diagnosis

AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency (NCT00924638)
Timeframe: Follow-up closure

Reviews

2 reviews available for aspirin and Cardio-embolic Stroke

Trials

10 trials available for aspirin and Cardio-embolic Stroke

Other Studies

4 other studies available for aspirin and Cardio-embolic Stroke