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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02596126
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : October 7, 2022
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Cardiovascular Disease Drug: Cardiovascular Polypill Drug: Treatment Prevention for Secondary CV Phase 3

Detailed Description:

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:

  • Cardiovascular Polypill (containing Aspirin, Ramipril, and Atorvastatin)
  • Usual care

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

Study Design
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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2499 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Secondary Prevention of Cardiovascular Disease in the Elderly Trial
Study Start Date : July 2016
Actual Primary Completion Date : October 31, 2021
Actual Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
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..
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Change in Treatment Adherence [ Time Frame: 6 months after patient treatment ]
    The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered

  9. Change in Treatment Adherence [ Time Frame: 24 months after patient treatment ]
    The Morisky-Medication Adherence Scale (8 item) Questionnaire will be administered

  10. Change in Patient Satisfaction [ Time Frame: 6 months after patient treatment ]
    The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered

  11. Change in Patient Satisfaction [ Time Frame: 24 months after patient treatment ]
    The treatment Satisfaction Questionnaire for Medication (TSQM) will be administered

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Change in LDL cholesterol level [ Time Frame: Baseline ]
    Non-fasting blood analysis will be collected and LDL cholesterol level evaluated at each timepoint.

  17. 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.

  18. 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.

  19. Regional differences in performance of the polypill in the previous endpoints [ Time Frame: 6 months after patient treatment ]
    Assessed

  20. Regional differences in performance of the polypill in the previous endpoints [ Time Frame: 12 months after patient treatment ]
    Assessed

  21. Regional differences in performance of the polypill in the previous endpoints [ Time Frame: 24 months after patient treatment ]
    Assessed

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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).

  28. 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).

  29. 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).

  30. 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).

  31. 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).

  32. 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).

  33. 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).


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596126


Locations
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Sponsors and Collaborators
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
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
Layout table for investigator information
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
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
ClinicalTrials.gov Identifier: NCT02596126    
Other Study ID Numbers: 633765
2015-002868-17 ( EudraCT Number )
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: October 7, 2022
Last Verified: August 2021
Keywords provided by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III:
Polypill
Prevention of Secondary Cardiovascular Disease
Cardiovascular Disease
Myocardial Infarction
Cardiovascular Combination Polypill AAR
Cardiovascular Disease in the Elderly
Adherence
 SECURE
Elderly
Secondary Cardiovascular Disease
Secondary Cardiovascular Prevention
Randomized Cardiovascular Trial
Randomized Trial
Cardiovascular Polypill
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Cardiovascular Diseases
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Vascular Diseases
Neoplastic Processes
Neoplasms
Platelet Aggregation Inhibitors