Ramipril 10 mg/Day Prevention

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

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.

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.