Secondary Prevention of Cardiovascular Disease in the Elderly Trial (SECURE)

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction; Cardiovascular Disease

Treatments: Drug: Treatment Prevention for Secondary CV; Drug: Cardiovascular Polypill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02596126

2015-002868-17 (EudraCT Number)

633765

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,499 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with a type 1 myocardial infarction within the previous 6 months.

2. Subjects must be ≥65 years old, presenting with at least one of the following additional conditions:

   • Documented diabetes mellitus or previous treatment with oral hypoglycemic drugs or insulin.
   • Mild to moderate renal dysfunction: creatinine clearance 60-30 mL/min/1.73 m2.
   • Prior myocardial infarction: defined as an AMI occurring before the index event documented in a medical report.
   • Prior coronary revascularization: coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
   • Prior stroke: history of a documented stroke, defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue, not resulting in death.
   • Age ≥ 75 years.

3. Signing informed consent.

Exclusion criteria

1. Unable to sign informed consent.
2. Contraindications to any of the components of the polypill.
3. Living in a nursing home.
4. Mental illness limiting the capacity of self-care.
5. Participating in another clinical trial.
6. Severe congestive heart failure (NYHA III-IV).
7. Severe renal disease (Creatinine Clearance (CrCl) <30ml/min/1.73 m2).
8. Need for oral anticoagulation at the time of randomization or planned in the future months.
9. Any condition limiting life expectancy <2 years, including but not limited to active malignancy.
10. Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation).
11. Scheduled coronary revascularization (patients can be randomized after final revascularization is completed within the prespecified timeframe).
12. Do not agree to the filing, forwarding and use of his/ her pseudonymised data.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,499 participants in 2 patient groups

Treatment Prevention for Secondary CV

Active Comparator group

Description:

Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians..

Treatment:

Drug: Treatment Prevention for Secondary CV

Cardiovascular Polypill

Experimental group

Description:

Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day.

Treatment:

Drug: Cardiovascular Polypill