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Secondary Prevention of Cardiovascular Disease in the Elderly Trial (SECURE)

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ClinicalTrials.gov Identifier: NCT02596126
Recruitment Status : Recruiting
First Posted : November 4, 2015
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
Charite University, Berlin, Germany
Centre Hospitalier Universitaire de Besancon
Wroclaw Medical University
Semmelweis University
General University Hospital, Prague
Servicio Madrileño de Salud, Madrid, Spain
London School of Hygiene and Tropical Medicine
Ferrer Internacional S.A.
Istituto Di Ricerche Farmacologiche Mario Negri
Information provided by (Responsible Party):
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Tracking Information
First Submitted Date  ICMJE October 5, 2015
First Posted Date  ICMJE November 4, 2015
Last Update Posted Date August 6, 2019
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
Difference in the occurrence of Major Adverse Cardiovascular Events (MACE) between the Cardiovascular Combination Polypill AAR and the Standard of Care Treatment [ Time Frame: 24 months ]
Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
Major Adverse Cardiovascular Events [ Time Frame: At 6 months, 12 months, 18 months, and 24 months ]
  • Cardiovascular death
  • Any nonfatal type 1 myocardial infarction
  • Any nonfatal ischemic stroke
  • Any urgent coronary revascularization not resulting in death
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
  • Incidence of the first occurrence of any component of the following composite endpoint: CV death, MI, stroke. [ Time Frame: Baseline ]
    Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
  • Incidence of the first occurrence of any component of the following composite endpoint: CV death, MI, stroke. [ Time Frame: 6 months after treatment initiation ]
    Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
  • Incidence of the first occurrence of any component of the following composite endpoint: CV death, MI, stroke. [ Time Frame: 12 months after treatment initiation ]
    Cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent revascularization
  • Evaluate the first occurrence of the individual components of the primary endpoint [ Time Frame: 18 months after treatment initiation ]
    • CV death.
    • Nonfatal type 1 myocardial infarction.
    • Nonfatal ischemic stroke.
    • Urgent coronary revascularization.
  • Evaluate the first occurrence of the individual components of the primary endpoint [ Time Frame: 24 months after treatment initiation ]
    • CV death.
    • Nonfatal type 1 myocardial infarction.
    • Nonfatal ischemic stroke.
    • Urgent coronary revascularization.
  • Evaluate the first occurrence of the individual components of the primary endpoint [ Time Frame: 36 months after treatment initiation ]
    • CV death.
    • Nonfatal type 1 myocardial infarction.
    • Nonfatal ischemic stroke.
    • Urgent coronary revascularization.
  • Evaluate the first occurrence of the individual components of the primary endpoint [ Time Frame: 48 months after treatment initiation ]
    • CV death.
    • Nonfatal type 1 myocardial infarction.
    • Nonfatal ischemic stroke.
    • Urgent coronary revascularization.
  • Change in Treatment Adherence [ Time Frame: 6 months after patient treatment ]
    The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered
  • Change in Treatment Adherence [ Time Frame: 24 months after patient treatment ]
    The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered
  • Change in Patient Satisfaction [ Time Frame: 6 months after patient treatment ]
    The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered
  • Change in Patient Satisfaction [ Time Frame: 24 months after patient treatment ]
    The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered
  • Change in Systolic and Diastolic Blood Pressure (SBP and DBP) [ Time Frame: Baseline ]
    Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
  • Change in Systolic and Diastolic Blood Pressure (SBP and DBP) [ Time Frame: 6 months after patient treatment ]
    Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
  • Change in Systolic and Diastolic Blood Pressure (SBP and DBP) [ Time Frame: 12 months after patient treatment ]
    Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
  • Change in Systolic and Diastolic Blood Pressure (SBP and DBP) [ Time Frame: 24 months after patient treatment ]
    Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
  • Change in LDL cholesterol level [ Time Frame: Baseline ]
    Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.
  • Change in LDL cholesterol level [ Time Frame: 12 months after patient treatment ]
    Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.
  • Change in LDL cholesterol level [ Time Frame: 24 months after patient treatment ]
    Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.
  • Regional differences in performance of the polypill in the previous endpoints [ Time Frame: 6 months after patient treatment ]
    Assessed
  • Regional differences in performance of the polypill in the previous endpoints [ Time Frame: 12 months after patient treatment ]
    Assessed
  • Regional differences in performance of the polypill in the previous endpoints [ Time Frame: 24 months after patient treatment ]
    Assessed
  • Health Economic Evaluation Comparing Intervention and Usual Care Arm [ Time Frame: 6 months after patient treatment ]
    Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.
  • Health Economic Evaluation Comparing Intervention and Usual Care Arm [ Time Frame: 12 months after patient treatment ]
    Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.
  • Health Economic Evaluation Comparing Intervention and Usual Care Arm [ Time Frame: 24 months after patient treatment ]
    Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.
  • Change in Quality of Life [ Time Frame: Baseline ]
    The European Quality of Life- 5 Dimensions (EQ-5D) Questionnaire will be administered at each timepoint to evaluate change in quality of life.
  • Change in Quality of Life [ Time Frame: 24 months after patient treatment ]
    The European Quality of Life- 5 Dimensions (EQ-5D) Questionnaire will be administered at each timepoint to evaluate change in quality of life.
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Baseline ]
    All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 6 months after patient treatment ]
    All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 12 months after patient treatment ]
    All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 18 months after patient treatment ]
    All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 24 months after patient treatment ]
    All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 36 months after patient treatment ]
    All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 48 months after patient treatment ]
    All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
  • Evaluate the Efficacy of Treatment [ Time Frame: At 6 months, 12 months, 18 months, and 24 months ]
    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 [ Time Frame: At 6 months, 12 months, 18 months, and 24 months ]
    • CV death.
    • Nonfatal type 1 myocardial infarction.
    • Nonfatal ischemic stroke.
    • Urgent coronary revascularization.
  • Change in Treatment Adherence [ Time Frame: At Baseline and 24 months ]
    The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered
  • Change in Patient Satisfaction [ Time Frame: At Baseline and 24 months ]
    The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered
  • Change in Systolic and Diastolic Blood Pressure (SBP and DBP) [ Time Frame: At 6 months, 12 months, and 24 months ]
    Systolic and diastolic blood pressure will be collected and summarized at each timepoint.
  • Change in LDL cholesterol level [ Time Frame: At Baseline, 12 months, and 24 months ]
    Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.
  • Regional differences in performance of the polypill in the previous endpoints [ Time Frame: At 6 months, 12 months, 18 months, and 24 months ]
    Assessed
  • Health Economic Evaluation Comparing Intervention and Usual Care Arm [ Time Frame: At 6 months, 12 months, and 24 months ]
    Cost differences and Incremental Cost-Effectiveness Ratio (ICER) will be assessed at each timepoint.
  • Change in Quality of Life [ Time Frame: At baseline and 24 months ]
    The European Quality of Life- 5 Dimensions (EQ-5D) Questionnaire will be administered at each timepoint to evaluate change in quality of life.
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: At 6 months, 12 months, 18 months, and 24 months ]
    All-cause mortality and adverse events (bleeding, renal dysfunction, drug, allergies, and refractory cough leading to drug discontinuation).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Official Title  ICMJE Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Brief Summary 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.
Detailed Description

A total number of 3206 patients will be 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 4 years.

There will be 3 follow up visits at month 6, 12 and 24 and telephone follow up calls at month 18, 36 and 48

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Myocardial Infarction
  • Cardiovascular Disease
Intervention  ICMJE
  • Drug: Cardiovascular Polypill

    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 Name: Polypill
  • Drug: Treatment Prevention for Secondary CV
    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
Study Arms  ICMJE
  • Active Comparator: Treatment Prevention for Secondary CV
    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..
    Intervention: Drug: Treatment Prevention for Secondary CV
  • Experimental: Cardiovascular Polypill
    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.
    Intervention: Drug: Cardiovascular Polypill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 2, 2015)
3206
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    • 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.
  3. Signing informed consent.

Exclusion Criteria:

  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).
  11. Scheduled coronary revascularization (patients can be randomized after final revascularization is completed within the prespecified timeframe).
  12. Do not agree to the filing, forwarding and use of his/ her pseudonymised data.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jose Maria Castellano Vazquez, MD, PhD josemaria.castellano@cnic.es
Contact: Antonio Quesada Navidad, PhD aquesada@cnic.es
Listed Location Countries  ICMJE Czechia,   France,   Germany,   Hungary,   Italy,   Poland,   Spain
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02596126
Other Study ID Numbers  ICMJE 633765
2015-002868-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Study Sponsor  ICMJE Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Collaborators  ICMJE
  • Charite University, Berlin, Germany
  • Centre Hospitalier Universitaire de Besancon
  • Wroclaw Medical University
  • Semmelweis University
  • General University Hospital, Prague
  • Servicio Madrileño de Salud, Madrid, Spain
  • London School of Hygiene and Tropical Medicine
  • Ferrer Internacional S.A.
  • Istituto Di Ricerche Farmacologiche Mario Negri
Investigators  ICMJE
Principal Investigator: Valentin Fuster, MD, PhD Centro Nacional de Investigaciones Cardiovasculares Carlos III
Study Director: Jose Maria Castellano Vazquez, MD, PhD Centro Nacional de Investigaciones Cardiovasculares Carlos III
PRS Account Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP