Additional identifiers
EudraCT/CTIS number
2011-000783-98
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL2-16257-095
Study information
Scientific title
Effects 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
Acronym
Study hypothesis
To 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
Study design
Exploratory open label study
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Coronary artery disease
Intervention
1. Two film-coated tablets of 7.5 mg or 5 mg of ivabradine
2. Control: placebo bid
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Ivabradine
Primary outcome measure
1. 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 measures
1. 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 date
01/09/2011
Overall study end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
15
Total final enrolment
15
Participant exclusion criteria
1. 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
Recruitment start date
01/09/2011
Recruitment end date
30/09/2012
Locations
Countries of recruitment
Italy
Study participating centre
San Raffaele University
Milan
20132
Italy
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan:
Summary results are published in https://clinicaltrials.servier.com.
Intention to publish date
Individual participant data (IPD) sharing plan
The 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.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | 20/04/2020 | No | No |