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

Not Applicable

Completed

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

• Registration Number: ISRCTN66067800
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief 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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-25
• Study Completion: 2009-03-31
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Cardiac markers (successive measurements during the 24 hours post-drug administration)<br>2. Echocardiography parameters (6 to 48 hours post-drug administration)<br>3. Magnetic resonance imaging parameters (sub-study) prior to discharge and at month 4<br>4. Pharmacokinetics measurements (during 24 hours post-study drug administration)