The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction

This study has been completed.
Sponsor:
Information provided by:
Servier
ClinicalTrials.gov Identifier:
NCT00143507
First received: August 31, 2005
Last updated: June 22, 2015
Last verified: June 2015
Results First Received: May 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Coronary Disease
Ventricular Dysfunction, Left
Interventions: Drug: Ivabradine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible participants were men and women, with documented history of coronary artery disease, associated with left ventricular systolic dysfunction. Angina and/or heart failure symptoms should have been stable for ≥ 3 months, with optimal conventional cardiovascular medication on appropriate stable doses for at least 1 month.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following a run-in period of two weeks during which no study treatment was dispensed, the participants were randomised to receive ivabradine or placebo in addition to their usual cardiovascular treatment in double-blind treatment period.

Reporting Groups
  Description
Ivabradine Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
Placebo Patients received placebo twice daily.

Participant Flow:   Overall Study
    Ivabradine     Placebo  
STARTED     5479     5438  
COMPLETED     4792     4786  
NOT COMPLETED     687     652  
Death                 572                 547  
Withdrawal by Subject                 114                 102  
Lost to Follow-up                 1                 0  
Withdrawn by sponsor's decision                 0                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ivabradine Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
Placebo Patients received placebo twice daily.
Total Total of all reporting groups

Baseline Measures
    Ivabradine     Placebo     Total  
Number of Participants  
[units: participants]
  5479     5438     10917  
Age  
[units: years]
Mean (Standard Deviation)
  65.3  (8.5)     65  (8.4)     65.2  (8.5)  
Gender  
[units: participants]
     
Female     939     931     1870  
Male     4540     4507     9047  
Beta-blocker intake  
[units: participants]
     
Yes     4749     4738     9487  
No     730     700     1430  



  Outcome Measures
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1.  Primary:   Primary Composite Endpoint   [ Time Frame: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years. ]

2.  Secondary:   Cardiovascular Death   [ Time Frame: From the date of randomisation to death, up to 3 years. ]

3.  Secondary:   Hospitalisation for Acute Myocardial Infarction   [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years. ]

4.  Secondary:   Hospitalisation for New Onset or Worsening Heart Failure   [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years. ]

5.  Secondary:   All-cause of Mortality   [ Time Frame: From the date of randomisation to death, up to 3 years. ]

6.  Secondary:   Coronary Artery Disease Death   [ Time Frame: From the date of randomisation to death, up to 3 years. ]

7.  Secondary:   Hospitalisation for Coronary Revascularisation   [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years. ]

8.  Secondary:   Hospitalisation for Unstable Angina   [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years. ]

9.  Secondary:   Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)   [ Time Frame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years. ]

10.  Secondary:   Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation   [ Time Frame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years. ]

11.  Secondary:   Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation   [ Time Frame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years. ]

12.  Secondary:   Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure   [ Time Frame: From the date of randomisation to the date of first occurrence of the first event, up to 3 years. ]

13.  Secondary:   Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction   [ Time Frame: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The section Other Adverse Events (Not including serious) has been completed by the sponsor to include only the Non Serious Adverse Events emergent on treatment during the study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Innovation Pole
Organization: Institut de Recherches Internationales Servier (I.R.I.S.)
phone: +33155724366
e-mail: clinicaltrials@servier.com


No publications provided by Servier

Publications automatically indexed to this study:

ClinicalTrials.gov Identifier: NCT00143507     History of Changes
Other Study ID Numbers: CL3-16257-056
Study First Received: August 31, 2005
Results First Received: May 13, 2015
Last Updated: June 22, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)