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)

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: RAMIPRIL HOE498

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Bali, Indonesia
    • Sanofi Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ramipril; 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; Pharmaceutical form:Tablet Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): April 23, 2010
• Study Completion (Actual): April 23, 2010

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Ramipril
• Other Study ID Numbers: RAMIP_L_03123; U1111-1193-0859 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org