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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 elevation

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 elevation

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005122-31-ES
Enrollment
75
Registered
2006-03-09
Start date
2006-04-25
Completion date
Unknown
Last updated
2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction MedDRA version: 3.3 Level: PT Classification code 10028596

Interventions

Product Name: Ivrabadine Product Code: S16257-F45 Pharmaceutical Form: Solution for infusion INN or Proposed INN: ivabradine CAS Number: 155974-00-8 Current Sponsor code: S16257-02 Concentration unit:

Sponsors

Institut de Recherches Internationales (for France)
Lead Sponsor
International Centre for Therapeutic Research (for Spain)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: Compare the effects of ivabradine on cardiac parameters versus placebo in patients after a percutaneous coronary intervention following a myocardial infarction with ST segment elevation.;Secondary Objective: Assess the safety and tolerability of ivabradine, the pharmacokinetics of ivabradine.;Primary end point(s): Cardiac parameters.—

Countries

Belgium, Germany, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026