aspirin and Atherosclerosis

aspirin has been researched along with Atherosclerosis in 304 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class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group.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.

Atherosclerosis: A thickening and loss of elasticity of the walls of ARTERIES that occurs with formation of ATHEROSCLEROTIC PLAQUES within the ARTERIAL INTIMA.

Research

Studies (304)

Authors

Clinical Trials (39)

Trial Overview

Trial Outcomes

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.

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)

Number of Participants Experiencing All-cause Death

(NCT02697916)
Timeframe: Time of randomization through study completion, approximately 4 years

Number of Participants Experiencing All-cause Death, Hospitalization for Nonfatal MI, or Hospitalization for Nonfatal Stroke in High-risk Patients With a History of MI or Documented Atherosclerotic Cardiovascular Disease (ASCVD)

(NCT02697916)
Timeframe: Time of randomization through study completion, approximately 4 years

Number of Participants Experiencing Hospitalization for Major Bleeding Complications With an Associated Blood Product Transfusion

(NCT02697916)
Timeframe: Time of randomization through study completion, approximately 4 years

Number of Participants Experiencing Hospitalization for Nonfatal MI

(NCT02697916)
Timeframe: Time of randomization through study completion, approximately 4 years

Number of Participants Experiencing Hospitalization for Nonfatal Stroke

(NCT02697916)
Timeframe: Time of randomization through study completion, approximately 4 years

Number of Participants Requiring Coronary Revascularization Procedures (Percutaneous Coronary Intervention [PCI] or Coronary Artery Bypass Grafting [CABG])

(NCT02697916)
Timeframe: Time of randomization through study completion, approximately 4 years

Quality of Life and Functional Status, as Measured on a 5-point Scale

Quality of life measures are based on an ordinal scale from 1-5, where 1 corresponds to the best outcome and 5 to the worst. Model-based mean score estimates are obtained from mixed models of each quality of life measure. (NCT02697916)
Timeframe: 2 years

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

Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization

Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization (NCT01225562)
Timeframe: Randomization up to 47 months

Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients

A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug (NCT01225562)
Timeframe: First dosing up to 48 months

Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization

Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization (NCT01225562)
Timeframe: Randomization up to 47 months

Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization

Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization (NCT01225562)
Timeframe: Randomization up to 47 months

Number of Participants With BARC Type 2, 3, or 5

Number of participants with first occurrence of clinically relevant bleeding episode, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding. BARC bleeding types range from 0 (no bleeding) to 5 (fatal bleeding). (NCT02270242)
Timeframe: 12 months after randomization

Number of Participants With Ischemic Episode

Number of participants with first occurrence of confirmed all-cause death, non-fatal myocardial infarction or stroke. (NCT02270242)
Timeframe: 12 months after randomization

Reviews

94 reviews available for aspirin and Atherosclerosis

Trials

53 trials available for aspirin and Atherosclerosis