Evaluation versus placebo of the effects on heart rate, haemodynamic parameters, safety and tolerability of 5 mg bolus of ivabradine followed by 8-hour infusion of 5 mg of ivabradine, given to patients undergoing a percutaneous coronary intervention following a myocardial infarction with ST segment elevation (STEMI): a pilot, blind, randomised, placebo-controlled, international, multi-centre study including the ancillary sub-study to the clinical study protocol
| ISRCTN | ISRCTN66067800 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66067800 |
| EudraCT/CTIS number | 2005-005122-31 |
| Secondary identifying numbers | CL2-16257-060 |
- Submission date
- 06/08/2008
- Registration date
- 25/09/2008
- Last edited
- 18/04/2018
- 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 Philippe Steg
Scientific
Scientific
Centre Hospitalier Bichat-Claude Bernard
Cardiology Department
46 rue Henri Huchard
Paris
75877
France
Study information
| Study design | Randomised, blinded, placebo-controlled, two parallel and unbalanced treatment arms study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation versus placebo of the effects on heart rate, haemodynamic parameters, safety and tolerability of 5 mg bolus of ivabradine followed by 8-hour infusion of 5 mg of ivabradine, given to patients undergoing a percutaneous coronary intervention following a myocardial infarction with ST segment elevation (STEMI): a pilot, blind, randomised, placebo-controlled, international, multi-centre study including the ancillary sub-study to the clinical study protocol |
| Study acronym | VIVIFY |
| Study objectives | Evaluate the effect of ivabradine over placebo on heart rate and haemodynamic parameters. |
| Ethics approval(s) | The First French Ethics Committee gave approval on the 11/01/2006 from CCPPRB paris-Pitié-Salpêtrière (dossier 103-05) |
| Health condition(s) or problem(s) studied | Acute myocardial infarction with ST segment elevation (STEMI) leading to a percutaneous coronary intervention |
| Intervention | Intravenous injection of 5 mg/placebo, followed by 5 mg/placebo infusion during 8 hours of ivabradine. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ivabradine |
| Primary outcome measure | Effect on heart rate and blood pressure from the time of drug administration to 24 hours. |
| Secondary outcome measures | 1. Cardiac markers (successive measurements during the 24 hours post-drug administration) 2. Echocardiography parameters (6 to 48 hours post-drug administration) 3. Magnetic resonance imaging parameters (sub-study) prior to discharge and at month 4 4. Pharmacokinetics measurements (during 24 hours post-study drug administration) |
| Overall study start date | 19/05/2006 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Male or female of non-childbearing potential, aged 40 to 80 years 2. Patients who are undergoing a percutaneous coronary intervention following an acute myocardial infarction with ST segment elevation 3. Sinus rhythm 4. Heart rate greater than 80 beats per minute 5. Systolic blood pressure greater than 90 mmHg |
| Key exclusion criteria | 1. Sick sinus syndrome, second-degree or third degree atrioventricular (AV) block 2. Atrial fibrillation or flutter 3. Hypertrophic cardiomyopathy, severe valvular disease or congenital disease 4. Moderate or severe liver disease 5. Unstable vital signs at clinical examination, stage IV Killip heart failure 6. Moderate or severe renal failure as measured by glomerular filtration rate (GFR) less than 60 ml/min/1.73m^2 of body surface area |
| Date of first enrolment | 19/05/2006 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- Australia
- Belgium
- France
- Germany
- Spain
Study participating centre
Centre Hospitalier Bichat-Claude Bernard
Paris
FR-75877
France
FR-75877
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"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 share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication plan: Summary results are published in https://clinicaltrials.servier.com. |
| 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 | |||
| Results article | results | 01/09/2013 | Yes | No |
Editorial Notes
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.
