The ARRIVE Study (Aspirin to Reduce Risk of Initial Vascular Events) - A Randomized, Double-Blind,Placebo Controlled, Multicenter, 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. - ARRIVE

Phase 1

Conditions: Patients at moderate risk of CHD events (10-20% 10-year risk
approximate 20-30% 10-year risk of CVD).
MedDRA version: 9.1Level: LLTClassification code 10028596Term: Myocardial infarction

Registration Number: EUCTR2006-003622-29-IT

Lead Sponsor: BAYER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12000

Inclusion Criteria

1. Males aged 50 years and above with 2 or 3 risk factors Male Risk Factors Males aged 60 and above 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 (*smoking cannot be the sole risk factor for males aged 60 and above) 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) 2. 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) 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) 3. An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Clinical history of CVD, MI, stroke, coronary artery angioplasty or stenting,coronary artery bypass graft, relevant arrhythmias, or congestive heart failure 2. Patients who are at higher than moderate risk on the basis of: a) their diabetes status (i.e. those with Type I or Type II diabetes actively treated with drug therapy) b) other factors known to the investigator (e.g. a male patient over 60 years of age with 4 or more risk factors) c) the currently used national risk score 3. 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 4. Lactating women or women of childbearing potential 5. Known increased risk of bleeding, e.g., gastric or duodenal ulcer, genitourinary causes or other bleeding disorders. 6. Known/diagnosed reflux esophagitis. 7. Moderately impaired renal function based on the clinical judgment of the investigator. 8. Severe liver disease or damage based on the clinical judgment of the investigator. 9. A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDs 10. History of hypersensitivity or drug allergy to acetylsalicylic acid 11. A definite indication for acetylsalicylic acid therapy, other anti-platelet drug, or anticoagulant in the opinion of the physician 12. Chronic, frequent (> 5 days/month) use of NSAIDs, COX-2 inhibitors or metamizole (acetaminophen/paracetamol and other non NSAID pain medications will be permitted) 13. Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is 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 (10-20% 10-year risk; approximate 20-30% 10-year risk of CVD).;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of the 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the same patient population.;Primary end point(s): The primary efficacy endpoint will be a composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke.

Secondary Outcome Measures