NCT02596126.

Trial name or title	Secondary Prevention of Cardiovascular Disease in the Elderly Trial (SECURE)
Methods	Randomised, open‐label, parallel‐assignment
Participants	A total number of 3206 participants will be randomized (1:1) to treatment arms. Participants will be recruited across seven countries in Europe (Spain, Italy, Germany, France, Hungary, Poland, and Czech Republic) Participants will be ≥ 65 years old and diagnosed with a type 1 myocardial infarction within 8 weeks prior to study enrolment Inclusion criteria Participants diagnosed with a type 1 myocardial infarction within the previous 8 weeks. Participants 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.
Interventions	(A) aspirin 100 mg, atorvastatin 40 mg, and ramipril (2.5 mg, or 5 mg, or 10mg) or (B) aspirin 100 mg, atorvastatin 20 mg, and ramipril (2.5 mg, or 5 mg, or 10mg) Other name: Polypill Comparator: participants 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
Outcomes	Primary outcome measures Major adverse cardiovascular events Cardiovascular death Any nonfatal type 1 myocardial infarction Any nonfatal ischaemic stroke Any urgent coronary revascularisation not resulting in death Secondary Outcomes Evaluate the efficacy of treatment: incidence of the first occurrence of any component of the following composite endpoint: CV death MI stroke Evaluate the first occurrence of the individual components of the primary endpoint: CV death Nonfatal type 1 myocardial infarction Nonfatal ischaemic stroke Urgent coronary revascularisation Change in treatment adherence: the Morisky‐Medication Adherence Scale (8 item) Questionnaire will be administered Change in Patient Satisfaction: the Treatment Satisfaction Questionnaire for Medication (TSQM) will be administered Change in systolic and diastolic blood pressure (SBP and DBP): systolic and diastolic blood pressure will be collected and summarised at each time point Change in LDL cholesterol level: non‐fasting blood analysis will be collected and LDL cholesterol level evaluated at each time point Regional differences in performance of the polypill in the previous endpoints Health economic evaluation comparing intervention and usual care arm Cost differences and Incremental Cost‐Effectiveness Ratio (ICER) will be assessed at each time point Change in quality of life: the European Quality of Life‐ 5 Dimensions (EQ‐5D) Questionnaire will be administered at each time point to evaluate change in quality of life. Incidence of treatment‐emergent adverse events (safety and tolerability) (time frame: 24 months) All‐cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation)
Starting date	January 2016
Contact information	Jose Maria Castellano Vazquez, MD, PhD, josemaria.castellano@cnic.es
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