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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

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Ivabradine and Metoprolol Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
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
Study Start Date : December 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ivabradine
Patients will recieved ivabradine(5) 1 tab bid pc for 3 day and the day of CT, and recieve placebo of metoprolol
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
Drug: Ivabradine and Metoprolol



Primary Outcome Measures :
  1. Heart rate of patient before CT coronary [ Time Frame: 1 January 2013 to 31 december 2013 ]

Secondary Outcome Measures :
  1. safety and side effect of Metoprolol and Ivabradine [ Time Frame: 1 january 2013 to 31 december 2013 ]

Other Outcome Measures:
  1. Image quality [ Time Frame: 1 january 2013 to 31 december 2013 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755663


Contacts
Contact: Purich Surunchupakorn, M.D. 081-988-7390 winnermd57@gmail.com

Locations
Thailand
Phramonkutklao Hospital Not yet recruiting
Bangkok, Thailand, 10400
Contact: Purich Surunchupakorn, M.D.    081-988-7390    winnermd57@gmail.com   
Principal Investigator: Purich - Surunchupakorn, M.D.         
Sponsors and Collaborators
Col. Suthee Panichkul
Phramongkutklao College of Medicine and Hospital
Investigators
Principal Investigator: Purich - Surunchupakorn, M.D. Phramongkutklao College of Medicine and Hospital

Responsible Party: Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier: NCT01755663     History of Changes
Other Study ID Numbers: Pharmongkutklao
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

Keywords provided by Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital:
CT coronary
Coronary arterial disease
ivabradine
metoprolol

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action