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 (HOPETips)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: RAMIPRIL HOE498

Study type: Interventional

Funder types: Industry

Identifiers

NCT03099213

U1111-1193-0859 (Other Identifier)

RAMIP_L_03123

Details and patient eligibility

About

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).

Full description

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

Enrollment: 179 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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179 participants in 1 patient group

Ramipril

Experimental group

Description:

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.

Treatment:

Drug: RAMIPRIL HOE498