Condition category
Circulatory System
Date applied
06/08/2008
Date assigned
25/09/2008
Last edited
08/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Philippe Steg

ORCID ID

Contact details

Centre Hospitalier Bichat-Claude Bernard
Cardiology Department
46 rue Henri Huchard
Paris
FR-75877
France

Additional identifiers

EudraCT number

2005-005122-31

ClinicalTrials.gov number

Protocol/serial number

CL2-16257-060

Study information

Scientific title

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 below 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 measures

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

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

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes