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

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

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).

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

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.