aspirin and Cardiac Failure

aspirin has been researched along with Cardiac Failure in 391 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class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group.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 (391)

Authors

Clinical Trials (25)

Trial Overview

Trial Outcomes

Long Term Primary End Point

Survival at 2 years free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device (NCT02224755)
Timeframe: The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.

Powered Secondary End Point: Pump Replacement at Two Years

In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HeartMate II is the control. (NCT02224755)
Timeframe: As they occur up to 24 months or to Outcome, whichever occurs first

Rehospitalizations

Rate of all cause rehospitalization (NCT02224755)
Timeframe: From initial discharge to two years post-implant

Short Term Primary End Point

Survival at 6 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device (NCT02224755)
Timeframe: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.

Adverse Event Rates

Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol (NCT02224755)
Timeframe: Two years post-implant

EuroQoL 5D-5L (EQ-5D-5L) Total Score

Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life. (NCT02224755)
Timeframe: Baseline to 24 months

EuroQol-5D-5L Visual Analogue Scale

Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life. (NCT02224755)
Timeframe: Baseline to 24 months

Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms. (NCT02224755)
Timeframe: Baseline to 24 months

New York Heart Association (NYHA) Classification

Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort. (NCT02224755)
Timeframe: Baseline to 24 months

Six Minute Walk Test

Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging. (NCT02224755)
Timeframe: Baseline to 24 months

All-cause Mortality

Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

All-cause Mortality in LTOLE Part

Count of participants from COMPASS LTOLE initiation visit to death by all cause were evaluated. LTOLE: long-term open-lable extension (NCT01776424)
Timeframe: For each participants, death by any cause after COMPASS LTOLE initiation visit up until the the last LTOLE part contact date was considered. The mean time in follow-up until that date was 428 days.

The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death

Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death

Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death

Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death in LTOLE Part

Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. LTOLE: long-term open-lable extension (NCT01776424)
Timeframe: For each participant, the first occurrence of the composite primary efficacy outcome after from COMPASS LTOLE initiation visit up until last LTOLE part contact date was considered. The mean time in follow-up was 428 days.

The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria

"Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).~Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis." (NCT01776424)
Timeframe: For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria in LTOLE Part

"Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).~Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the primary safety outcome major bleeding was evaluated. LTOLE: long-term open-lable extension" (NCT01776424)
Timeframe: For each participant, the first occurrence of modified ISTH major bleeding from COMPASS LTOLE initiation visit up until 2 days after the last treatment in LTOLE part was considered. The mean time in follow-up was 421 days.

Number of Patients With All Cause Death and Non-fatal Stroke

This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With All Cause Death and Shock

This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With All Cause Death and Shock and CHF

This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported. (NCT00623623)
Timeframe: 30 days

Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke

This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With All Cause Death and Shock and Reinfarction

This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With All Cause Mortality

This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported. (NCT00623623)
Timeframe: 30 days

Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.

The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS). (NCT00623623)
Timeframe: 30 days

Number of Patients With Cardiac Mortality

This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported. (NCT00623623)
Timeframe: 30 days

Number of Patients With Cardiogenic Shock

This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported. (NCT00623623)
Timeframe: 30 days

Number of Patients With Congestive Heart Failure (CHF)

This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported. (NCT00623623)
Timeframe: 30 days

Number of Patients With Intracranial Haemorrhage

This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Ischaemic Stroke

This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions

This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Minor Non-intracranial Bleeds

This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Recurrent Myocardial Infarction (Reinfarction)

This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Rehospitalisation for Cardiac Reasons

This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Rehospitalisation for Non-cardiac Reasons

This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Serious Repeat Target Vessel Revascularization

This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Serious Resuscitated Ventricular Fibrillation

This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures

This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Total Disabling Stroke

This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Total Fatal Stroke

This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Total Non-disabling Stroke

This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Total Non-intracranial Bleeds

This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported (NCT00623623)
Timeframe: 30 days

Number of Patients With Total Stroke (All Types)

This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported (NCT00623623)
Timeframe: 30 days

Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death

The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years

Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome

Time, in years, from randomization to death component of secondary composite outcome. This measure counts only deaths that were not preceded by heart failure hospitalization, myocardial infarction, ischemic stroke, or intracerebral hemorrhage. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization to date of death component of secondary composite outcome, up to 6 years

Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.

Time, in years, from date of randomization to date of heart failure hospitalization, up to 6 years. Includes hospitalizations for heart failure during follow-up that were not preceded by myocardial infarction. Event rate per 100 patient years = 100*(number of subjects with heart failure hospitalization)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years

Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome

Time, in years, from date of randomization to date of intracerebral hemorrhage component of secondary composite outcome. Includes only intracerebral hemorrhages not preceded by myocardial infarction or heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years

Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome

Ischemic stroke component of secondary composite endpoint. Includes only ischemic strokes that were not preceded by a myocardial infarction or heart failure hospitalization. The number of ischemic strokes that are components of the secondary outcome does not therefore match the number of ischemic strokes that are components of the primary outcome. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years

Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome

Time, in years, from date of randomization to date of myocardial infarction, up to 6 years. Includes only myocardial infarctions that occurred during follow-up, before any heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with myocardial infarction)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years

Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.

"The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years.~Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25." (NCT00041938)
Timeframe: From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.

Event Rate Per 100 Patient-years for Death

Time, in years, from date of randomization to date of death component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization to date of death component of primary composite outcome, up to 6 years

Event Rate Per 100 Patient-years for Intracerebral Hemorrhage

Time, in years, from date of randomization to date of intracerebral hemorrhage component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years

Event Rate Per 100 Patient-years for Ischemic Stroke

Time, in years, from date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years

Rate Per 100 Patient Years of Major Hemorrhage

Rate/100 patient-years of major hemorrhage. Includes all major hemorrhages in any patient. Major hemorrhage was defined as intracerebral, epidural, subdural, subarachnoid, spinal intramedullary, or retinal hemorrhage; any other bleeding causing a decline in the hemoglobin level of more than 2 g per deciliter in 48 hours; or bleeding requiring transfusion of 2 or more units of whole blood, hospitalization, or surgical intervention. Event rate per 100 patient years = 100*(number of major hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization until end of scheduled follow-up, up to 6 years

Rate Per 100 Patient-years of Minor Hemorrhage.

Rate per 100 patient years of minor hemorrhage. Includes all minor hemorrhages. Minor hemorrhage was defined as any non-major hemorrhage. Event rate per 100 patient years = 100*(number of minor hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25. (NCT00041938)
Timeframe: From date of randomization until the end of scheduled follow-up, up to 6 years

Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure

Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to Global treatment end date (approximately 54 months)

Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke

Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient [pt]-year [yr]) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to Global treatment end date (approximately 54 months)

Event Rate of Bleeding Events That Requiring Hospitalization

Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to 227 Weeks

Event Rate of Cardio Vascular Death

Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to Global treatment end date (approximately 54 months)