Comparison of Efficacy of Ivabradine Versus Metoprolol (IMAGE)

• ClinicalTrials.gov Identifier: NCT01755663
• Recruitment Status: Unknown
• First Posted: December 24, 2012
• Last Update Posted: October 29, 2014
• Sponsor: Col. Suthee Panichkul
• Collaborator: Phramongkutklao College of Medicine and Hospital
• Information provided by (Responsible Party): Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital

Tracking Information

• First Submitted Date: December 19, 2012
• First Posted Date: December 24, 2012
• Last Update Posted Date: October 29, 2014
• Study Start Date: December 2014
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 21, 2012): Heart rate of patient before CT coronary [ Time Frame: 1 January 2013 to 31 december 2013 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 21, 2012): safety and side effect of Metoprolol and Ivabradine [ Time Frame: 1 january 2013 to 31 december 2013 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: December 21, 2012): Image quality [ Time Frame: 1 january 2013 to 31 december 2013 ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Comparison of Efficacy of Ivabradine Versus Metoprolol
• 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
• Brief Summary: Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Diagnostic
• Condition: Coronary Artery Disease
• Intervention: Drug: Ivabradine and Metoprolol

Study Arms

• Experimental: Ivabradine
  Patients will recieved ivabradine(5) 1 tab bid pc for 3 day and the day of CT, and recieve placebo of metoprolol
  Intervention: Drug: Ivabradine and Metoprolol
• Active Comparator: metoprolol
  Metoprolol (100) 1/2 tab bid pc for 3 day and the day of CT coronary , and placebo of ivabradine
  Intervention: Drug: Ivabradine and Metoprolol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 21, 2012): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2015
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT01755663
• Other Study ID Numbers: Pharmongkutklao
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital
• Study Sponsor: Col. Suthee Panichkul
• Collaborators: Phramongkutklao College of Medicine and Hospital

Investigators

• Principal Investigator: Purich - Surunchupakorn, M.D.; Phramongkutklao College of Medicine and Hospital

• PRS Account: Phramongkutklao College of Medicine and Hospital
• Verification Date: October 2014