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Comparison of Efficacy of Ivabradine Versus Metoprolol (IMAGE)

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ClinicalTrials.gov Identifier: NCT01755663
Recruitment Status : Unknown
Verified October 2014 by Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2012
Last Update Posted : October 29, 2014
Sponsor:
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  ICMJE December 19, 2012
First Posted Date  ICMJE December 24, 2012
Last Update Posted Date October 29, 2014
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2012)
Heart rate of patient before CT coronary [ Time Frame: 1 January 2013 to 31 december 2013 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Comparison of Efficacy of Ivabradine Versus Metoprolol
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Drug: Ivabradine and Metoprolol
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 21, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755663
Other Study ID Numbers  ICMJE Pharmongkutklao
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital
Study Sponsor  ICMJE Col. Suthee Panichkul
Collaborators  ICMJE Phramongkutklao College of Medicine and Hospital
Investigators  ICMJE
Principal Investigator: Purich - Surunchupakorn, M.D. Phramongkutklao College of Medicine and Hospital
PRS Account Phramongkutklao College of Medicine and Hospital
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP