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Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure (SIGNIFY)

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: NCT02446990
Recruitment Status : Completed
First Posted : May 18, 2015
Results First Posted : June 25, 2015
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Ivabradine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure. A Randomised Double-blind Placebo-controlled International Multicenter Study. Study Assessing the Morbi-mortality Benefits of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease
Study Start Date : September 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ivabradine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ivabradine Drug: Ivabradine
5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
Placebo Comparator: Placebo Drug: Placebo
Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Composite Endpoint [ Time Frame: The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months. ]
    First event among cardiovascular death or non-fatal myocardial infarction


Secondary Outcome Measures :
  1. All-cause Mortality [ Time Frame: From the date of randomisation to death, up to 48 months ]
  2. Cardiovascular Mortality [ Time Frame: From the date of randomisation to death, up to 48 months ]
    Component of the primary composite endpoint

  3. Coronary Mortality [ Time Frame: From the date of randomisation to death, up to 48 months ]
    Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death

  4. Fatal Myocardial Infarction [ Time Frame: From the date of randomisation to death, up to 48 months ]
    Non-composite secondary endpoint

  5. Non-fatal Myocardial Infarction [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months ]
    Component of the primary composite endpoint

  6. Elective Coronary Revascularisation [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months ]
    Non-composite secondary endpoint

  7. Coronary Revascularisation (Elective or Not) [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months ]
    Non-composite secondary endpoint

  8. Secondary Composite Endpoint [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months ]
    Fatal or non-fatal myocardial infarction

  9. Secondary Composite Endpoint [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months ]
    Fatal or non-fatal myocardial infarction, coronary revascularisation

  10. Secondary Composite Endpoint [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months ]
    Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina

  11. Secondary Composite Endpoint [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months ]
    Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke

  12. Secondary Composite Endpoint [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months ]
    Coronary death, non-fatal myocardial infarction

  13. Secondary Composite Endpoint [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 48 months ]
    Non-fatal myocardial infarction, coronary revascularisation, unstable angina


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evidence of coronary artery disease
  • Sinus rhythm and resting heart rate equal or higher than 70 bpm

Exclusion Criteria:

  • Unstable cardiovascular condition
  • Known hypersensitivity to ivabradine or current treatment with marketed ivabradine
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): NCT02446990


Locations
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Italy
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy, 44100
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Institut de Recherches Internationales Servier
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT02446990    
Other Study ID Numbers: CL3-16257-083
2009-011360-10 ( EudraCT Number )
First Posted: May 18, 2015    Key Record Dates
Results First Posted: June 25, 2015
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: http://clinicaltrials.servier.com
Additional relevant MeSH terms:
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Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases