Heart and Blood Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Myocardial Infarction

Infarction

Neoplasm Metastasis

Ischemia

Necrosis

Coronary Artery Disease

Myocardial Ischemia

Heart Diseases

Vascular Diseases

Neoplastic Processes

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Lipid Regulating Agents

Antihypertensive Agents

Aspirin

Atorvastatin

Ramipril

Hypolipidemic Agents

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..

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.

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).

Cardiovascular Polypill

ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.

Treatment Prevention for Secondary CV

Valentin Fuster, MD, PhD

Jose Maria Castellano Vazquez, MD, PhD

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.

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

Secondary Prevention of Cardiovascular Disease in the Elderly Trial

Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization

* CV death.
* Nonfatal type 1 myocardial infarction.
* Nonfatal ischemic stroke.
* Urgent coronary revascularization.

The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered

The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered

Systolic and diastolic blood pressure will be collected and summarized at each timepoint.

Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.

Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.

The European Quality of Life- 5 Dimensions (EQ-5D) Questionnaire will be administered at each timepoint to evaluate change in quality of life.

All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Secondary Prevention of Cardiovascular Disease in the Elderly Trial	NCT02596126	Myocardial Infa... Cardiovascular ...	Cardiovascular ... Treatment Preve...	65 Years -	Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Secondary Prevention of Cardiovascular Disease in the Elderly Trial	NCT02596126	Myocardial Infa... Cardiovascular ...	Cardiovascular ... Treatment Preve...	65 Years -	Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

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