Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI

NSTEMI Clinical Trial

Official title:

The Efficacy of Oral Ivabradine in Patients Presenting With Acute Non ST-segment Elevation Myocardial Infarction (NSTEMI): Interventional Randomized Parallel Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285736
• Other study ID #: CL1200
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2014
• Est. completion date: May 2016

Study information

• Verified date: February 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Non-ST Elevated Myocardial Infarction
• NSTEMI

Intervention

Drug:
• Ivabradine
Ivabradine (5mg twice daily)
• Conventional Treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	National Heart Institute, Egypt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Heart Rate Reduction	acute stage post percutaneous coronary intervention (3-5 days)