drugset / Trial / NCT02596126
Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Phase 3
Completed
2499 enrolled
National Center for Cardiovascular Research Carlos III
Centre Hospitalier Universitaire de Besancon · collabCharite University, Berlin, Germany · collabFerrer Internacional S.A. · collabGeneral University Hospital, Prague · collabIstituto Di Ricerche Farmacologiche Mario Negri · collabLondon School of Hygiene and Tropical Medicine · collabSemmelweis University · collabServicio Madrileño de Salud, Madrid, Spain · collabWroclaw Medical University · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2016-07
- Primary completion
- 2021-10-31
- Completion
- 2022-03-31
Publications
- Castellano JM, Pocock SJ, Bhatt DL, Quesada AJ, Owen R, Fernandez-Ortiz A, Sanchez PL, Marin Ortuno F, Vazquez Rodriguez JM, Domingo-Fernandez A, Lozano I, Roncaglioni MC, Baviera M, Foresta A, Ojeda-Fernandez L, Colivicchi F, Di Fusco SA, Doehner W, Meyer A, Schiele F, Ecarnot F, Linhart A, Lubanda JC, Barczi G, Merkely B, Ponikowski P, Kasprzak M, Fernandez Alvira JM, Andres V, Bueno H, Collier T, Van de Werf F, Perel P, Rodriguez-Manero M, Alonso Garcia A, Proietti M, Schoos MM, Simon T, Fernandez Ferro J, Lopez N, Beghi E, Bejot Y, Vivas D, Cordero A, Ibanez B, Fuster V; SECURE Investigators. Polypill Strategy in Secondary Cardiovascular Prevention. N Engl J Med. 2022 Sep 15;387(11):967-977. doi: 10.1056/NEJMoa2208275. Epub 2022 Aug 26.
- Buttgereit T, Palmowski A, Forsat N, Boers M, Witham MD, Rodondi N, Moutzouri E, Navidad AJQ, Van't Hof AWJ, van der Worp B, Coll-Planas L, Voshaar M, de Wit M, da Silva J, Stegemann S, Bijlsma JW, Koeller M, Mooijaart S, Kearney PM, Buttgereit F. Barriers and potential solutions in the recruitment and retention of older patients in clinical trials-lessons learned from six large multicentre randomized controlled trials. Age Ageing. 2021 Nov 10;50(6):1988-1996. doi: 10.1093/ageing/afab147.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 100 mg | Oral |
| Subject | Atorvastatin | Small molecule | 20 mg | Oral |
| Subject | Atorvastatin | Small molecule | 40 mg | Oral |
| Subject | Ramipril | Small molecule | 2.5 mg | Oral |
| Subject | Ramipril | Small molecule | 5 mg | Oral |
| Subject | Ramipril | Small molecule | 10 mg | Oral |