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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 : June 18, 2018
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

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 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 3206 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
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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




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).



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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.

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


Contacts
Contact: Jose Maria Castellano Vazquez, MD, PhD josemaria.castellano@cnic.es
Contact: Ester Cunha Pavon ecunha@cnic.es

  Show 101 Study Locations
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
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

Additional Information:
Responsible Party: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
ClinicalTrials.gov Identifier: NCT02596126     History of Changes
Other Study ID Numbers: 633765
2015-002868-17 ( EudraCT Number )
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: February 2018

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:
Infarction
Cardiovascular Diseases
Myocardial Infarction
Neoplasm Metastasis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Neoplastic Processes
Neoplasms
Ramipril
Platelet Aggregation Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents