Comparison of Efficacy of Ivabradine Versus Metoprolol (IMAGE)

This study is not yet open for participant recruitment.
Verified October 2013 by Phramongkutklao College of Medicine and Hospital
Sponsor:
Collaborator:
Phramongkutklao College of Medicine and Hospital
Information provided by (Responsible Party):
Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier:
NCT01755663
First received: December 19, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Drug: Ivabradine and Metoprolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Phramongkutklao College of Medicine and Hospital:

Primary Outcome Measures:
  • Heart rate of patient before CT coronary [ Time Frame: 1 January 2013 to 31 december 2013 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety and side effect of Metoprolol and Ivabradine [ Time Frame: 1 january 2013 to 31 december 2013 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Image quality [ Time Frame: 1 january 2013 to 31 december 2013 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier: NCT01755663     History of Changes
Other Study ID Numbers: Pharmongkutklao
Study First Received: December 19, 2012
Last Updated: October 23, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by 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
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on April 16, 2014