Clinical trial NCT03099213: 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
Official title: A Study of Patients Treated With Ramipril for Cardiovascular Risk Reduction The HOPE Tips: The HOPE Study Translated Into PracticeS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 179
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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

Eligibility 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.

Primary outcomes:
measure: Total patients with tolerability score Very Good
timeFrame: 12 weeks
measure: Total patients with tolerability score Good
timeFrame: 12 weeks
measure: Total patients with tolerability score Sufficient
timeFrame: 12 weeks
measure: Total patients with tolerability score Insufficient
timeFrame: 12 weeks
measure: Total patients with tolerability score Not Good
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Adverse Events or Serious Adverse Events reported
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bali
country: Indonesia
facility: Sanofi Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: