Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI

NCT ID: NCT04285736

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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NSTEMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A Ivabradine Group

Group Type EXPERIMENTAL

Ivabradine

Intervention Type DRUG

Ivabradine (5mg twice daily)

Group B Control Group

Group Type ACTIVE_COMPARATOR

Ivabradine

Intervention Type DRUG

Ivabradine (5mg twice daily)

Conventional Treatment

Intervention Type DRUG

Interventions

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Ivabradine

Ivabradine (5mg twice daily)

Intervention Type DRUG

Conventional Treatment

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart Institute, Egypt

OTHER_GOV

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Samar Farghali Farid

Professor and Head of Clinical Pharmacy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CL1200

Identifier Type: -

Identifier Source: org_study_id

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