Conditions: Moderate Risk of CVD
Keywords: Primary prevention of coronary heart disease Stroke and cardiovascular death Aspirin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12546
Healthy volunteers: no

Brief 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.

Detailed description:
Summary of substantial Protocol amendments

Amendment #2 from 09-APR-2008:

* Systolic blood pressure (SBP) limit of 170 mmHg has been added to the exclusion criteria
* Exclusion of patients currently taking anticoagulant medication
* A longer interval between the daily dose of study drug and ibuprofen
* Revised wording in moderate risk definitions for coronary heart disease (CHD) and cerebrovascular disease (CVD): "To evaluate the clinical effects of a 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events (approximately 10 to 20% 10-year CHD risk; approximately 20 to 30% 10-year risk of CVD). This corresponds to a patient population mean 10-year CVD risk of approximately 30%."

Amendment #3 from 02-JAN-2009

• Increase in the number of allowed risk factors for males, age is no longer a risk factor

Amendment #4 from 02-OCT-2013

* The primary endpoint is changed to include confirmed UA and TIA.
* The estimated event rate is changed to 1.5% per year due to new information.
* Effect size (risk reduction) changed from 14.9% to 17 to 18%.
* Achieving 60,000 person-years instead of 1488 primary endpoint events
* Additional treatment and follow-up for a maximum of another 12 months.
* Change to reduced adverse event and concomitant therapy reporting

Arms:
arm 1: Participants received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily. arm 2: Participants received 1 tablets of matching placebo orally once daily.

Interventions: intervention 1: Aspirin (Acetylsalicylic acid, BAYE4465) intervention 2: Placebo
Intervention descriptions: intervention 1: 100mg enteric coated Aspirin, taken daily intervention 2: Placebo, taken daily

Protocol document: