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 |
| Clinical Trials Information System (CTIS) | 2011-000783-98 |
| Protocol serial number | CL2-16257-095 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
San Raffaele University
Insititute of Science
Via Olgettina 60
Milan
20132
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Exploratory open label study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ivabradine |
| Primary outcome measure(s) |
1. Myocardial stunning, by evaluating changes in regional wall motion measuring 2D Strain/Strain rate |
| Key secondary outcome measure(s) |
1. Arterial elastance, measured at selection visit, inclusion visit and end of treatment visit |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 15 |
| Total final enrolment | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- Italy
Study participating centre
20132
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | 20/04/2020 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
