Overview

This trial is active, not recruiting.

Condition moderate risk of cvd
Treatments aspirin (acetylsalicylic acid, baye4465), placebo
Phase phase 3
Sponsor Bayer
Start date July 2007
End date November 2016
Trial size 12551 participants
Trial identifier NCT00501059, 12198, 2006-003622-29

Summary

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied. However, the overall risk level of the study populations was low (< 10% 10-year CHD 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
aspirin (acetylsalicylic acid, baye4465)
100mg enteric coated Aspirin, taken daily
(Placebo Comparator)
placebo
Placebo, taken daily

Primary Outcomes

Measure
Time to first occurrence of the composite outcome of MI, stroke, cardiovascular death, UA (unstable angina) or TIA (transient ischemic attack)
time frame: Approximately 6 years of follow-up (duration of planned treatment phase)

Secondary Outcomes

Measure
Time to first occurrence of the composite outcome of cardiovascular death, ACS (Acute Coronary Syndrome), or stroke
time frame: Approximately 6 years of follow-up (duration of planned treatment phase)
Time to first occurrence of the individual components of the primary: non-fatal MI, total MI, non-fatal stroke, total stroke, cardiovascular death, UA or TIA
time frame: Approximately 6 years of follow-up (duration of planned treatment phase)
Time to incidence of all cause mortality
time frame: Approximately 6 years of follow-up (duration of planned treatment phase)
Time to first occurrence of/ incidence of all cancers, excluding non melanoma skin cancer
time frame: Approximately 6 years of follow-up (duration of planned treatment phase)
Time to first occurrence of/ incidence of colon cancer
time frame: Approximately 6 years of follow-up (duration of planned treatment phase)
Incidence of MI, stroke, UA, TIA and CV death separately
time frame: Approximately 6 years of follow-up (duration of planned treatment phase)
Incidence of treatment-emergent adverse events (observed and reported), and changes in the physical examination findings, weight, and vital signs
time frame: Approximately 56 years of follow-up (duration of planned treatment phase)

Eligibility Criteria

Male or female participants at least 55 years old.

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<40 mg/dL; as measured at screening) - Elevated blood pressure (SBP>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<40 mg/dL; as measured at screening) - Elevated blood pressure (SBP>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

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bayer.