NCT02596126

Secondary Prevention of Cardiovascular Disease in the Elderly Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,499 (actual)
• Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of a polypill strategy containing aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the standard of care (usual care according to the local clinical practices at each participating country) in secondary prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.

Detailed description

A total number of 2499 patients have been randomized (1:1) to treatment arms. Patients will be recruited across seven countries in Europe (Spain, Italy, Germany, France, Hungary, Poland, and Czech Republic). Patients will be ≥65 years old and diagnosed with a type 1 myocardial infarction within 6 months prior to study enrolment. Once the inclusion and exclusion criteria are confirmed, patients will be included in the study after signing informed consent. Randomization will take place within 6 months of the index event (AMI type I) in a 1:1 ratio to one of the two arms: * Cardiovascular Polypill (containing Aspirin, Ramipril, and Atorvastatin) * Usual care Patients will be followed up for a minimum of 2 years and a maximum of 5 years. There will be 3 follow up visits at month 6, 12 and 24 and telephone follow up calls at month 18, 36, 48 and 60

Conditions

• Myocardial Infarction
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Cardiovascular Polypill	Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
DRUG	Treatment Prevention for Secondary CV	ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.

Timeline

• Start date: 2016-07-01
• Primary completion: 2021-10-31
• Completion: 2022-03-31
• First posted: 2015-11-04
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

113 sites across 7 countries: Czechia, France, Germany, Hungary, Italy, Poland, Spain