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Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI

Primary Purpose

NSTEMI

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ivabradine
Conventional Treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSTEMI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A Ivabradine Group

    Group B Control Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Heart Rate
    Heart Rate Reduction

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2020
    Last Updated
    February 24, 2020
    Sponsor
    Cairo University
    Collaborators
    National Heart Institute, Egypt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04285736
    Brief Title
    Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI
    Official Title
    The Efficacy of Oral Ivabradine in Patients Presenting With Acute Non ST-segment Elevation Myocardial Infarction (NSTEMI): Interventional Randomized Parallel Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (Actual)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University
    Collaborators
    National Heart Institute, Egypt

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NSTEMI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A Ivabradine Group
    Arm Type
    Experimental
    Arm Title
    Group B Control Group
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Ivabradine
    Intervention Description
    Ivabradine (5mg twice daily)
    Intervention Type
    Drug
    Intervention Name(s)
    Conventional Treatment
    Primary Outcome Measure Information:
    Title
    Heart Rate
    Description
    Heart Rate Reduction
    Time Frame
    acute stage post percutaneous coronary intervention (3-5 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI

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