Secondary Prevention of Cardiovascular Disease in the Elderly

Phase 1

• Conditions: Secondary Prevention of Major Cardiovascular Events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in post MI cohort.; MedDRA version: 20.0Level: LLTClassification code 10028597Term: Myocardial infarction acuteSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002868-17-DE
• Lead Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares, Carlos III (CNIC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-10
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3206

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:
I. Documented diabetes mellitus or previous treatment with oral hypoglycemic drugs or insulin.
ii. Mild to moderate renal dysfunction: creatinine clearance 60-30 mL/min/1.73 m2.
iii. Prior myocardial infarction: defined as an AMI occurring before the index event documented in a medical report.
iv. Prior coronary revascularization: coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
v. 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.
vi. Age = 75 years.
3. Signing informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3206

Exclusion Criteria

1. Unable to sign informed consent.
2. Inability to understand and comply with the protocol requirements and instructions.
3. Contraindications to any of the components of the polypill.
4. Living in a nursing home or committed to an institution by virtue of and order issued by the judicial or the administrative authorities.
5. Mental illness limiting the capacity of self-care.
6. Participating in another clinical trial.
7. Severe congestive heart failure (NYHA III-IV).
8. Severe renal disease (Creatinine Clearance (CrCl) <30ml/min/1.73 m2).
9. Severe hepatic impairment. Liver cirrhosis transaminases exceeding 3 times the upper limit of the normal limit.
10. Allergies to lactose, peanut, or soy.
11. Need for oral anticoagulation at the time of randomization or planned in the future months.
12. Any condition limiting life expectancy <2 years, including but not limited to active malignancy.
13. Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation).
14. Scheduled coronary revascularization (patients can be randomized after final revascularization is completed within the pre-specified timeframe).
15. Do not agree to the filing, forwarding and use of his/ her pseudonymised data.
16. Individuals dependent from the sponsor, investigator or investigational site/institution.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified