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Clinical Trials/NCT04285736
NCT04285736
Completed
Phase 2

The Efficacy of Oral Ivabradine in Patients Presenting With Acute Non ST-segment Elevation Myocardial Infarction (NSTEMI): Interventional Randomized Parallel Study

Cairo University0 sites100 target enrollmentDecember 2014

Overview

Phase
Phase 2
Intervention
Ivabradine
Conditions
NSTEMI
Sponsor
Cairo University
Enrollment
100
Primary Endpoint
Heart Rate
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aims to evaluate the beneficial effect of heart rate reduction of oral ivabradine in patients presenting with non ST-segment elevation myocardial infarction (NSTEMI) during acute stage post percutaneous coronary intervention versus conventional treatment.

Materials and methods: A total of 100 patients admitted to the emergency department, National Heart Institute, Cairo, Egypt were randomized into two groups as follows: Group A: 50 patients with NSTEMI treated with ivabradine (5mg twice daily) in addition to the conventional treatment; Group B: 50 patients with NSTEMI treated with the conventional treatment only. Demographic data, detailed history, clinical examination, chest pain onset, blood pressure, heart rate (HR), temperature and respiratory rate, electrocardiogram (ECG) as well as echocardiography and laboratory investigations were recorded. Patients were monitored for a period of 3-5 days (acute stage).

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
May 2016
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Samar Farghali Farid

Professor and Head of Clinical Pharmacy Department

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients with NSTEMI with normal sinus rhythm and heart rate (HR) more than 70 beats per minute (bpm) and systolic blood pressure (SBP) \>90 mm Hg undergoing PCI

Exclusion Criteria

  • Patients needing urgent cardiac surgery, IV inotropic agents or had a HR less than 60 bpm without any medication.

Arms & Interventions

Group A Ivabradine Group

Intervention: Ivabradine

Group B Control Group

Intervention: Ivabradine

Group B Control Group

Intervention: Conventional Treatment

Outcomes

Primary Outcomes

Heart Rate

Time Frame: acute stage post percutaneous coronary intervention (3-5 days)

Heart Rate Reduction

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