Additional identifiers
EudraCT number
2005-005122-31
ClinicalTrials.gov number
Protocol/serial number
CL2-16257-060
Study information
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
Acronym
VIVIFY
Study hypothesis
Evaluate the effect of ivabradine over placebo on heart rate and haemodynamic parameters.
Ethics approval
The First French Ethics Committee gave approval on the 11/01/2006 from CCPPRB paris-Pitié-Salpêtrière (dossier 103-05)
Study design
Randomised, blinded, placebo-controlled, two parallel and unbalanced treatment arms study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
19/05/2006
Overall trial end date
31/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
19/05/2006
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Australia, Belgium, France, Germany, Spain
Trial participating centre
Centre Hospitalier Bichat-Claude Bernard
Paris
FR-75877
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
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.
IPD sharing statement:
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.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
http://clinicaltrials.servier.com/wp-content/uploads/CL2-16257-060_synopsis_report.pdf
Publication list
2013 results in:
Safety of intravenous ivabradine in acute ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention: a randomized, placebo-controlled, double-blind, pilot study
PG Steg, E Lopez-de-Sà, F Schiele, M Hamon, T Meinertz, J Goicolea, K Werdan, JL Lopez-Sendon, on behalf of the VIVIFY investigators
European Heart Journal: Acute Cardiovascular Care. 2013; 2:270-279