Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04285736
• Collaborator: National Heart Institute, Egypt (Other)
• Enrollment: 100
• Arms: 2
• Actual Duration (Months): 17

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
NSTEMI	Drug: Ivabradine; Drug: Conventional Treatment	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Oral Ivabradine in Patients Presenting With Acute Non ST-segment Elevation Myocardial Infarction (NSTEMI): Interventional Randomized Parallel Study
• Actual Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Ivabradine Group	Drug: Ivabradine; Ivabradine (5mg twice daily)
Active Comparator: Group B Control Group	Drug: Ivabradine; Ivabradine (5mg twice daily); Drug: Conventional Treatment

Outcome Measures

Primary Outcome Measures

1. Heart Rate [acute stage post percutaneous coronary intervention (3-5 days)]

   Heart Rate Reduction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University
• National Heart Institute, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samar Farghali Farid, Professor and Head of Clinical Pharmacy Department, Cairo University
• ClinicalTrials.gov Identifier: NCT04285736
• Other Study ID Numbers: CL1200
• First Posted: Feb 26, 2020
• Last Update Posted: Feb 26, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Non-ST Elevated Myocardial Infarction

Study Results

No Results Posted as of Feb 26, 2020