Ramipril 10 mg/Day Prevention

Sanofi

Status and phase: Completed; Phase 4

Conditions: Atherosclerosis

Treatments: Drug: Ramipril

Study type: Interventional

Funder types: Industry

Identifiers

NCT01053910

HOE498_4099

Details and patient eligibility

About

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.

Enrollment: 1,012 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,012 participants in 1 patient group

Ramipril

Experimental group

Description:

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)

Treatment:

Drug: Ramipril