Comparison of Efficacy of Ivabradine Versus Metoprolol (IMAGE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014