The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction
This study has been completed.
Sponsor:
Institut de Recherches Internationales Servier
Information provided by:
Servier
ClinicalTrials.gov Identifier:
NCT00143507
First received: August 31, 2005
Last updated: June 22, 2015
Last verified: June 2015
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Purpose
The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Disease Ventricular Dysfunction, Left |
Drug: Ivabradine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Ivabradine on Cardiovascular Events in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction. A Three-year Randomised Double-blind Placebo-controlled International Multicentre Study. |
Resource links provided by NLM:
MedlinePlus related topics:
Coronary Artery Disease
Drug Information available for:
Ivabradine
U.S. FDA Resources
Further study details as provided by Servier:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]First event among cardiovascular death, hospitalisation for acute myocardial infarction (fatal or not), or hospitalisation for new onset or worsening heart failure (fatal or not).
Secondary Outcome Measures:
- Cardiovascular Death [ Time Frame: From the date of randomisation to death, up to 3 years. ] [ Designated as safety issue: No ]Cardiovascular death including sudden death of unknown cause
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- All-cause of Mortality [ Time Frame: From the date of randomisation to death, up to 3 years. ] [ Designated as safety issue: No ]
- Coronary Artery Disease Death [ Time Frame: From the date of randomisation to death, up to 3 years. ] [ Designated as safety issue: No ]Death due to heart failure, acute myocardial infarction or cardiac procedure
- Hospitalisation for Coronary Revascularisation [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years. ] [ Designated as safety issue: No ]
- Hospitalisation for Unstable Angina [ Time Frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 10917 |
| Study Start Date: | December 2004 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ivabradine | Drug: Ivabradine |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Coronary artery disease
- Left ventricular systolic dysfunction
- Sinus rhythm: heart rate (HR) >= 60 beats per minute (bpm)
Exclusion Criteria:
- Unstable cardiovascular condition
- Severe congestive heart failure
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143507
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143507
Locations
| United Kingdom | |
| Royal Brompton National Heart and Lung Hospital | |
| London, United Kingdom, SW3 6NP | |
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Investigators
| Study Chair: | Kim Fox, MD | Royal Brompton National Heart and Lung Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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) |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Ventricular Dysfunction Ventricular Dysfunction, Left |
Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on September 27, 2016