The ARRIVE Study (Aspirin to Reduce Risk of Initial Vascular Events) - A Randomized, Double-Blind, Placebo Controlled, Multicenter, arallel 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: This will be a randomized, multicentre, double-blind, placebo controlled, parallelgroup trial in patients at moderate risk of CHD events
cardiovascular death, MI, or stroke.

Registration Number: EUCTR2006-003622-29-IE

Lead Sponsor: Bayer Consumer Care AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12000

Inclusion Criteria

The inclusion criteria are based on the National Heart, Lung and Blood Institute
(NHLBI) Framingham Heart Study (FHS) cardiovascular risk predictors.45
The ability of the selected inclusion criteria to procure a moderate risk population
was confirmed by modeling the criteria with PROCAM, Framingham and
SCORE risk calculators. All consenting patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

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)

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)

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

Patients presenting with any of the following will not be included in the trial:
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.