Secondary Prevention of Cardiovascular Disease in the Elderly - SECURE

Fundación Centro Nacional de Investigaciones Cardiovasculares, Carlos III (CNIC)0 sites3,206 target enrollmentFebruary 17, 2016

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Secondary Prevention of Major Cardiovascular Events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in post MI cohort.
Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares, Carlos III (CNIC)
Enrollment: 3206
Status: Active, not recruiting
Last Updated: 10 years ago

No summary available.

Registry

who.int

Start Date

February 17, 2016

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundación Centro Nacional de Investigaciones Cardiovasculares, Carlos III (CNIC)

•1\. Patients diagnosed with a type 1 myocardial infarction within the previous 8 weeks.
•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

•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).