Phase 3
N=12,546
A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Moderate Risk of CVD
Bottom Line
View on ClinicalTrials.gov: NCT00501059 ↗Enrolled (actual)
12,546
Serious AEs
20.5%
Results posted
Jan 2018
Primary outcome: Primary: Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) — 528; 381; 889; 796 Days — p=0.597
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aspirin (Acetylsalicylic acid, BAYE4465) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) |
528; 381; 889; 796; 1225; 1134 | 0.597 |
| SECONDARY Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown) |
678; 522; 1167; 1053; 1599; 1501 | 0.6125 |
| SECONDARY Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA |
1309; 1085; NA; 2121; 1216; 1014 | 0.4505 |
| SECONDARY Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer |
838; 938; 1493; 1460; 1970; 1963 | 0.9544 |
| SECONDARY Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer |
2.55; 2.57; 4.02; 3.76; 0.48; 0.41 | 0.9459 |
| SECONDARY Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately |
1.52; 1.78; 1.20; 1.07; 0.61; 0.62 | 0.2325 |
Summary
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.
Eligibility Criteria
Inclusion Criteria
- Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:
- Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment
- Current smoking: defined as any cigarette smoking in the past 12 months
- Low HDL cholesterol (HDL 140 mmHg; as measured at screening)
- Currently on any medication to treat high blood pressure
- Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
- Females aged 60 and above with 3 or more risk factors. Female Risk Factors:
- Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured at screening) irrespective of current treatment
- Current smoking: defined as any cigarette smoking in the past 12 months
- Low HDL cholesterol (HDL 140 mmHg; as measured at screening)
- Currently on any medication to treat high blood pressure
- Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
- An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial
Exclusion Criteria
- History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention
- Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
- Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
- Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
- Active diagnosed and documented reflux esophagitis
- Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
- Lactating women or women of childbearing potential
- Severe liver disease or damage based on the clinical judgment of the investigator
- Severe renal disease or damage based on the clinical judgement of the investigator
- A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
- A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
- Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
- Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
- Current use of an anticoagulant medication
- Sitting systolic blood pressure greater than 170 mmHg
Data sourced from ClinicalTrials.gov (NCT00501059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.