Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI
The Efficacy of Oral Ivabradine in Patients Presenting With Acute Non ST-segment Elevation Myocardial Infarction (NSTEMI): Interventional Randomized Parallel Study
1 other identifier
interventional
100
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2014
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
February 26, 2020
CompletedAugust 22, 2024
August 1, 2024
1.4 years
February 24, 2020
August 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Heart Rate
Heart Rate Reduction
acute stage post percutaneous coronary intervention (3-5 days)
Study Arms (2)
Group A Ivabradine Group
EXPERIMENTALGroup B Control Group
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients needing urgent cardiac surgery, IV inotropic agents or had a HR less than 60 bpm without any medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- National Heart Institute, Egyptcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Head of Clinical Pharmacy Department
Study Record Dates
First Submitted
February 24, 2020
First Posted
February 26, 2020
Study Start
December 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
August 22, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share