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

• Register: ISRCTN
• Last refreshed on: 21 May 2018
• Main ID: ISRCTN66067800
• Date of registration: 25/09/2008
• Prospective Registration: No
• Primary sponsor: Institut de Recherches Internationales Servier (France)
• Public 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
• 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
• Date of first enrolment: 19/05/2006
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN66067800
• Study type: Interventional
• Study design: Randomised, blinded, placebo-controlled, two parallel and unbalanced treatment arms study (Treatment)
• Phase: Not Specified

Countries of recruitment

Australia, Belgium, France, Germany, Spain

Contacts

• Name: Philippe Steg

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Acute myocardial infarction with ST segment elevation (STEMI) leading to a percutaneous coronary intervention
Circulatory System
Acute myocardial infarction

Intervention(s)

Intravenous injection of 5 mg/placebo, followed by 5 mg/placebo infusion during 8 hours of ivabradine.

Primary Outcome(s)

Effect on heart rate and blood pressure from the time of drug administration to 24 hours.

Secondary Outcome(s)

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)

Secondary ID(s)

2005-005122-31

CL2-16257-060

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Ethics review

Status:
Approval date:
Contact:

The First French Ethics Committee gave approval on the 11/01/2006 from CCPPRB paris-Pitié-Salpêtrière (dossier 103-05)

Results

• Results available: Yes
• Date Completed: 31/03/2009