Effects of ivabradine in patients with coronary artery disease and suffering from a reversible contractility dysfunction of the heart muscle

ISRCTN ISRCTN90566768
DOI https://doi.org/10.1186/ISRCTN90566768
EudraCT/CTIS number 2011-000783-98
Secondary identifying numbers CL2-16257-095
Submission date
09/06/2011
Registration date
18/10/2011
Last edited
20/04/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Prof Paolo G. Camici
Scientific

San Raffaele University
Insititute of Science
Via Olgettina 60
Milan
20132
Italy

Study information

Study designExploratory open label study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffects of oral administration of ivabradine (7.5 mg bid) on post-ischaemic stunning induced by exercise stress in patients with coronary artery disease and exercise inducible ischaemia
Study objectivesTo assess the effects of ivabradine on post-ischaemic stunning induced by exercise stress in patients with stable coronary artery disease and exercise-inducible ischaemia
Ethics approval(s)Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studiedCoronary artery disease
Intervention1. Two film-coated tablets of 7.5 mg or 5 mg of ivabradine
2. Control: placebo bid
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Ivabradine
Primary outcome measure1. Myocardial stunning, by evaluating changes in regional wall motion measuring 2D Strain/Strain rate
2. Measured at selection visit, inclusion visit and end of treatment visit
Secondary outcome measures1. Arterial elastance, measured at selection visit, inclusion visit and end of treatment visit
2. Ventricular arterial coupling, measured at selection visit, inclusion visit and end of treatment visit
3. Safety, measured at each visit
Overall study start date01/09/2011
Completion date30/09/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants15
Total final enrolment15
Key inclusion criteria1. Aged 30 to 75 years
2. Male or female
3. Evidence of coronary artery disease proven by clinical history
4. Sinus rhythm and resting heart rate equal or higher than 70 bpm
5. Exercise-inducible myocardial ischaemia
6. Myocardial stunning, assessed by cardiac echocardiography
Key exclusion criteria1. Angina at rest or angina class IV
2. Unstable cardiovascular condition
3. Previous treament with anti-anginal medication within 1 week before inclusion
4. Significant abnormalities in the laboratory blood evaluation
5. Contra-indication to the administration of ivabradine
Date of first enrolment01/09/2011
Date of final enrolment30/09/2012

Locations

Countries of recruitment

  • Italy

Study participating centre

San Raffaele University
Milan
20132
Italy

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website http://www.servier.com/
ROR logo "ROR" https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication plan:
Summary results are published in https://clinicaltrials.servier.com.
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results No No
Basic results 20/04/2020 No No

Editorial Notes

20/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD sharing statement added.
29/11/2017: Results summary added.