Coronary DiseasePhase 3NCT00143507

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

A Phase 3 study testing Ivabradine in people with Coronary Disease and Ventricular Dysfunction, Left, run by Institut de Recherches Internationales Servier at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Disease, Ventricular Dysfunction, Left
What is being tested?: Ivabradine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10,917 participants
Where: 1 siteUnited Kingdom
Study dates: Dec 2004to Feb 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Coronary artery disease
Left ventricular systolic dysfunction
Sinus rhythm: heart rate (HR) >= 60 beats per minute (bpm)

Who cannot join

Unstable cardiovascular condition
Severe congestive heart failure

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Royal Brompton National Heart and Lung Hospital
London, SW3 6NP

Other trials in United Kingdom

About this study

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.

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.

Conditions: Coronary Disease, Ventricular Dysfunction, Left
Being tested: Ivabradine, Placebo
Medical subject headings: Coronary Disease, Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IvabradineDrug
PlaceboDrug

Study groups in NCT00143507
Study group	Role	What they receive
Ivabradine	Experimental	Not described Receives: Drug: Ivabradine
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Composite Endpoint
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).
Measured: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.

Secondary outcomes (12)

Cardiovascular Death
Cardiovascular death including sudden death of unknown cause
Measured: From the date of randomisation to death, up to 3 years.
Hospitalisation for Acute Myocardial Infarction
Measured: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Hospitalisation for New Onset or Worsening Heart Failure
Measured: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
All-cause of Mortality
Measured: From the date of randomisation to death, up to 3 years.
Coronary Artery Disease Death
Death due to heart failure, acute myocardial infarction or cardiac procedure
Measured: From the date of randomisation to death, up to 3 years.
Hospitalisation for Coronary Revascularisation
Measured: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Hospitalisation for Unstable Angina
Measured: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)
Measured: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation
Measured: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation
Measured: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure
Measured: From the date of randomisation to the date of first occurrence of the first event, up to 3 years.
Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction
Measured: From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004Feb 2008

First posted2 Sep 2005 (estimated)
Study startDec 2004
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 10,917 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00143507
Sponsor's protocol ID: CL3-16257-056
Status last verified: Mar 2018
First submitted: 31 Aug 2005
Last updated: 12 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: 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.

Publications

Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. doi: 10.1016/S0140-6736(08)61170-8. Epub 2008 Aug 29.
PubMed 18757088

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00143507
Acronym / sponsor ID: CL3-16257-056
Conditions: Coronary Disease, Ventricular Dysfunction, Left
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 10,917 participants (actual)
Lead sponsor: Institut de Recherches Internationales ServierUniversity, hospital or other
Study start: Dec 2004
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 2 Sep 2005 (estimated)
Results: Posted 25 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ivabradine	Experimental	Drug: Ivabradine
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Coronary artery disease
Left ventricular systolic dysfunction
Sinus rhythm: heart rate (HR) >= 60 beats per minute (bpm)

Key exclusion criteria (2 listed)

Unstable cardiovascular condition
Severe congestive heart failure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ivabradine	Drug	Ivabradine
Placebo	Drug	Placebo

Primary outcome

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.
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).

12 secondary outcomes

Cardiovascular Death
Time frame: From the date of randomisation to death, up to 3 years.
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.
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.
All-cause of Mortality
Time frame: From the date of randomisation to death, up to 3 years.
Coronary Artery Disease Death
Time frame: From the date of randomisation to death, up to 3 years.
Hospitalisation for Coronary Revascularisation
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Hospitalisation for Unstable Angina
Time frame: From the date of randomisation to the date of first occurrence of the event, up to 3 years.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 25 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ivabradine	5,479	4,792
Placebo	5,438	4,786

Primary outcome: 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.. Number. Unit: participants

Measure	Ivabradine n = 5479	Placebo n = 5438
Value	844	832

Ivabradine vs Placebo: Hazard Ratio (HR): 1.00 (95% CI 0.91 to 1.10), p = 0.945, Regression, Cox

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From randomization to death, up to 3 years. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ivabradine	1,625 of 5,477 (29.7%)	2,570 of 5,477 (46.9%)	Not reported
Placebo	1,770 of 5,430 (32.6%)	2,221 of 5,430 (40.9%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 18757088Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. doi: 10.1016/S0140-6736(08)61170-8. Epub 2008 Aug 29.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kim Fox, MD study chair

Royal Brompton National Heart and Lung Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ivabradine in people with Coronary Disease and Ventricular Dysfunction, Left, run by Institut de Recherches Internationales Servier at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00143507, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.