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 CHD risk; approximately 30% 10-year risk of CVD events based on the underlyingassumption at study start).; MedDRA version: 19.0Level: LLTClassification code 10072760Term: Transient ischemic attackSystem Organ Class: 100000004852; MedDRA version: 19.0Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 100000004852; MedDRA version: 19.0Level: LLTClassification code 10046251Term: Unstable anginaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 19.0Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 19.0Level: PTClassification code 10049993Term: Cardiac deathSystem Organ Class: 10018065 - General disorders and administration site conditions

• Registration Number: EUCTR2006-003622-29-DE
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-14
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12000

Inclusion Criteria

- age
- elevated total cholesterol
- low HDL cholesterol
- elevated blood pressure
- family history of early CHD
- smoking
- on antihypertensive therapie

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

- type I and type II diabetes
- prior history of a CVD events (clinical or diagnostic)
- standard exclusion criterias for ASA (see protocol)
- any condition likely to cause death within 5 years
- chronic, frequent use of NSAID´s or COX-2 inhibitors

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified