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Effect of a Polypill on middle-aged and elderly Iranians

Completed
Conditions
Cardiovascular disease in middle-aged and older adults.
Circulatory System
Cardiovascular disease
Registration Number
ISRCTN43076122
Lead Sponsor
Ministry of Health and Medical Education (Iran)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
500
Inclusion Criteria

1. Men between the ages of 50 and 80 (inclusive)
2. Women aged 55 to 80 (inclusive)
3. Living in Kalaleh
4. Free from existing cardiovascular disease (stroke, Transient Ischaemic Attack [TIA], Myocardial Infarction [MI], or angina)
5. Not currently be taking or eligible for antihypertensive treatment, aspirin or statins

Exclusion Criteria

1. Total cholesterol levels exceed 240 mg/dL
2. Blood pressure exceeds 160/100 mmHg at baseline
3. People with existing vascular disease
4. Clear indication or contra-indication for any component of the polypill or other chronic medical problems that would interfere with participation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Combined cardiovascular events (MI, new onset angina, coronary artery surgery, stroke or sudden cardiac death)
Secondary Outcome Measures
NameTimeMethod
1. Total mortality <br>2. Gastrointestinal bleeding
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