NCT Number: NCT02596126
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.
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Notify Me65 year and older
All sexes
Interventional
Phase 3
Všeobecná fakultní nemocnice v Praze, Prague, Czechia
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:
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: Polypill
ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
Other names: Antiplatelet agents, Lipid Lowering Agents, Renin-angiotensin-aldosterone system blockers
Time frame: Up to 5 years
The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee:
Time frame: 6 months
Treatment adherence at 6 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.
Time frame: Up to 5 Years
All-cause mortality.
Time frame: 2 years
Treatment adherence at 24 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.
Time frame: 6 months
The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group.
Time frame: 12 months
The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group.
Time frame: 2 years
The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group.
Time frame: 6 months
The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.
Time frame: 12 months
The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.
Time frame: 2 years
The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.
Time frame: 12 months
Low-density lipoprotein (LDL) cholesterol levels measured in mg/dL at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.
Time frame: 2 years
Low-density lipoprotein (LDL) cholesterol levels measured in mg/dL at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.
Time frame: Up to 5 years
The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: Cardiovascular death (CV death); Acute Myocardial Infarction (MI) type 1; stroke. Measured in number of cases.
Time frame: Up to 5 years
The incidence of the first occurrence of the Cardiovascular (CV) death. Measured in number of cases.
Time frame: Up to 5 years
The incidence of the first occurrence of of the Nonfatal type 1 myocardial infarction. Measured in number of cases.
Time frame: Up to 5 years
The incidence of the first occurrence of the Nonfatal ischemic stroke. Measured in number of cases.
Time frame: Up to 5 years
The incidence of the first occurrence of the Urgent coronary revascularization. Measured in number of cases.
Time frame: 6 months
Domain "effectiveness" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (effectiveness) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 6 months
Domain "Side effects score" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain the response was on a Likert-type scale of 5 or 7 points, except for question 4 which a yes/no question about the presence of side effects is asked. If the answer to this question is no (no side effects reported by the participant), other questions will not be asked (questions 5 to 8), and the total score is automatically computed as the maximum of 100. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction.
Time frame: 6 months
Domain "Convenience score" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Convenience score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 6 months
Domain "Global satisfaction score" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Global satisfaction score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 24 months
Domain "effectiveness" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (effectiveness) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 24 months
Domain "Side effects score" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Side effects score) the response was on a Likert-type scale of 5 or 7 points, except for question 4 which a yes/no question about the presence of side effects is asked. If the answer to this question is no (no side effects reported by the participant), other questions will not be asked (questions 5 to 8), and the total score is automatically computed as the maximum of 100. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction.
Time frame: 24 months
Domain "Convenience score" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Convenience score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: 24 months
Domain "Global satisfaction score" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Global satisfaction score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).
Time frame: Up to 5 Years
The incidence of the first occurrence of the Non-cardiovascular death. Measured in number of cases.
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Other
Acronym: SECURE
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