Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiovascular Disease
- Myocardial Infarction
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 65 years and 125 years
- Gender
- Both males and females
Description
A total number of 3206 patients will be 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 mont...
A total number of 3206 patients will be 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 4 years. There will be 3 follow up visits at month 6, 12 and 24 and telephone follow up calls at month 18, 36 and 48
Tracking Information
- NCT #
- NCT02596126
- Collaborators
- Charite University, Berlin, Germany
- Centre Hospitalier Universitaire de Besancon
- Wroclaw Medical University
- Semmelweis University
- General University Hospital, Prague
- Servicio Madrileño de Salud, Madrid, Spain
- London School of Hygiene and Tropical Medicine
- Ferrer Internacional S.A.
- Istituto Di Ricerche Farmacologiche Mario Negri
- Investigators
- Principal Investigator: Valentin Fuster, MD, PhD Centro Nacional de Investigaciones Cardiovasculares Carlos III Study Director: Jose Maria Castellano Vazquez, MD, PhD Centro Nacional de Investigaciones Cardiovasculares Carlos III
Get Well Soon