An Open-label, Non-comparative Study to Document the Tolerability to Ramipril in Patients With at Least One High Risk for Developing a Major Cardiovascular Event

Study Overview
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Brief Summary
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Primary Objective: To document the tolerability of patients receiving study medication at 12-week of therapy in terms of the scoring system assessed by the investigator. Secondary Objectives: To document drug safety at 12-week of treatment in terms of number of Adverse Drug Reaction or Serious Adverse Drug Reaction reported. To describe the population treated as per the HOPE study indication in current clinical practice (demographics, cardiovascular risk-factors at treatment initiation, concomitant treatments patterns).

Detailed Description
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The duration of the study period is 8-12 weeks.

Official Title
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A Study of Patients Treated With Ramipril for Cardiovascular Risk Reduction The HOPE Tips: The HOPE Study Translated Into PracticeS

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: RAMIPRIL HOE498


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Man or woman, age 55 years old or more. Presence of a high risk of developing a major cardiovascular event, defined as at least one of the following underlying conditions: Clinical evidence of coronary artery disease (examples: previous myocardial infarction [MI], positive stress test or significant stenosis at coronary angiography, previous Percutaneous Trans-Luminal Coronary Angioplasty [PTCA], previous Coronary Arterial Bypass Grafting [CABG]); Clinical evidence of peripheral vascular disease (examples: history of intermittent claudication with positive Doppler or angiography, previous limb bypass surgery, previous percutaneous trans-luminal angioplasty, previous limb or foot amputation); Previous stroke; Diabetes (insulin-dependent or non-insulin dependent) with at least one of the following cardiovascular risk factors: hypertension (blood pressure [BP] >140/90 mmHg, or patients on antihypertensive treatment); hypercholesterolemia (total cholesterol > 5.2 mmol/L [>200 mg/dL]); low HDL cholesterol (< 0.9 mmol/L [<3.5 mg/dL]); current cigarette smoking; documented microalbuminuria (30-300 mg/24 hours); Evidence of previous vascular disease. Exclusion criteria: Patients with contraindications to ramipril use (as per the local Ramipril Product Information) hypersensitivity pregnancy, lactation bilateral renal stenosis Patients with clinically relevant concomitant disease that could compromise the patient's safety or follow up. 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: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramipril<br>Receiving ramipril with the recommended initial dose of 2.5 mg once daily; depending on the tolerability, the dose should be gradually increased. The increase should be implemented by doubling the dose after one to two weeks. Three or four weeks later, the dose should be doubled again up to the usual maintenance dose of 10 mg once daily. | Drug: RAMIPRIL HOE498<br>* Pharmaceutical form:Tablet Route of administration: Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total patients with tolerability score Very Good |  | 12 weeks | 
| Total patients with tolerability score Good |  | 12 weeks | 
| Total patients with tolerability score Sufficient |  | 12 weeks | 
| Total patients with tolerability score Insufficient |  | 12 weeks | 
| Total patients with tolerability score Not Good |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events or Serious Adverse Events reported |  | 12 weeks |