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Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Phase 3
Phase 2

Conditions

NSTEMI

Treatments

Drug: Ivabradine
Drug: Conventional Treatment

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

100 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Group A Ivabradine Group
Experimental group
Treatment:
Drug: Ivabradine
Group B Control Group
Active Comparator group
Treatment:
Drug: Conventional Treatment
Drug: Ivabradine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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