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NCT01755663 Clinical Trial

Comparison of Efficacy of Ivabradine Versus Metoprolol

Coronary Artery Disease Clinical Trial

— IMAGE  

Official title:
Comparison of Efficacy and Safety of Ivabradine Versus Metoprolol for Controlling Heart Rate Prior to 640-Slice Computed Tomographic Angiography in Elective Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01755663
Other study ID # Pharmongkutklao
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received December 19, 2012
Last updated October 27, 2014
Start date December 2014
Est. completion date December 2015

Study information
Verified date October 2014
Source Phramongkutklao College of Medicine and Hospital
Contact Purich Surunchupakorn, M.D.
Phone 081-988-7390
Email winnermd57@gmail.com
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date December 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- elective patient on scheduled for 640 slices CT coronary at Phramonkutklao hospital

- Resting heart rate > 70 BPM

- age > 18 years and informed consent

Exclusion Criteria:

- Heart rate > 100 BPM

- BP <100/60 mmHg

- recent congestive heart failure in 1 mo.

- SA node, AV node disease and AF

- on permanent pacemaker

- CrCL < 15ml/min. , AST or ALT > 3x UNL

- on HR reducing drug such as diltiazem, verapamil, digitalis

- contraindication for ivabradine or metoprolol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Ivabradine and Metoprolol

Locations
Country Name City State
Thailand Phramonkutklao Hospital Bangkok

Sponsors (2)
Lead Sponsor Collaborator
Col. Suthee Panichkul Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Other Image quality 1 january 2013 to 31 december 2013 Yes
Primary Heart rate of patient before CT coronary 1 January 2013 to 31 december 2013 Yes
Secondary safety and side effect of Metoprolol and Ivabradine 1 january 2013 to 31 december 2013 Yes
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