Ramipril 10 mg/Day Prevention

Study Overview
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Brief Summary
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The objective is to investigate the safety of ramipril 10 mg/day used in prevention of cardiovascular events in high-risk patients, including the criteria of the HOPE study.

Official Title
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A Multicentre Open, Non Comparative Study of the Safety of Ramipril (Tritace) 10 mg/Day in Prevention of Cardiovascular Events in High-risk Patients

Conditions
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Atherosclerosis

Intervention / Treatment
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* Drug: Ramipril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of coronary artery disease, Stroke Stable heart failure Peripheral vascular disease, or diabetes with at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, cigarette smoking, or documented microalbuminuria). Exclusion Criteria: Non stabilized or NYHA grade IV heart failure patients Hemodynamically significant primary valvular or outflow tract obstruction (eg. mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve) Constrictive pericarditis. Complex congenital heart disease. Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic cardiac arrhythmias including ventricular tachycardia are not an exclusion criterion). Planned cardiac surgery or angioplasty within 3 months (patient may be reconsidered for the trial after the procedure). Cor pulmonale. Heart transplant recipient. Significant renal disease defined as: Renal artery stenosis; Creatine clearance <0.6 ml/second or serum creatinine≥ 200 mEq/L (≥2.26 mg/dl) Overt nephropathy: ≥1 plus proteinuria on dipstick or urinary albumin excretion > 200 micrograms/minute (300 mg/24 hrs) Hyperkalemia; K>5.5 mEq/L. Patient is simultaneously taking another experimental drug. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramipril<br>Duration of treatment: 2 months 7 first days: 1.25mg once daily in patients with stable heart failure and 7 days 2.5mg once daily or 14 first days:2.5mg once daily in patients without heart failure for 14 more days:5mg once daily maintenance therapy for 1 month: 10 mg (5mg, 2 tablets) | Drug: Ramipril<br>* tablet of Ramipril once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient reaching the 10mg/day dose level |  | 30 days after the treatment start | 
| Overall number of adverse events |  | at day 7 (visit 2), day 15 (visit 3), day 30 (visit 4), day 45 (visit 5) and day 60 (final visit) |