Evaluation of the effects on heart rate, haemodynamic parameters, safety and tolerability of 5 mg bolus of ivabradine followed by 8-hour infusion at the dose of 5 mg of ivabradine given after a percutaneous coronary intervention following a myocardial infarction with ST segment elevatio

Phase 1

• Conditions: Acute Myocardial Infarction; MedDRA version: 3.3Level: PTClassification code 10028596

• Registration Number: EUCTR2005-005122-31-ES
• Lead Sponsor: Institut de Recherches Internationales (for France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-09
• Study Completion: 2009-04-20
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

- Male or female patients,
- aged between 40 and 80 years (inclusive),
- HR > 80 bpm in sinus rythm,
- patients who underwent a Percutaneous Coronary Intervention following an acute myocardial infarction with ST segment elevation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Sick sinus syndrome;
- second-degree or third-degree AV block;
- trifascicular block and PR > 240 ms;
- hypertrophic cardiomyopathy, severe valvular disease, or severe congenital heart disease;
- suspected aortic dissection;
- known relevant electrolyte disorders.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified