NCT01755663

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
1.9 years until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

Same day

First QC Date

December 19, 2012

Last Update Submit

October 27, 2014

Conditions

Keywords

CT coronaryCoronary arterial diseaseivabradinemetoprolol

Outcome Measures

Primary Outcomes (1)

  • Heart rate of patient before CT coronary

    1 January 2013 to 31 december 2013

Secondary Outcomes (1)

  • safety and side effect of Metoprolol and Ivabradine

    1 january 2013 to 31 december 2013

Other Outcomes (1)

  • Image quality

    1 january 2013 to 31 december 2013

Study Arms (2)

Ivabradine

EXPERIMENTAL

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

metoprolol

ACTIVE COMPARATOR

Metoprolol (100) 1/2 tab bid pc for 3 day and the day of CT coronary , and placebo of ivabradine

Drug: Ivabradine and Metoprolol

Interventions

Ivabradinemetoprolol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective patient on scheduled for 640 slices CT coronary at Phramonkutklao hospital
  • Resting heart rate \> 70 BPM
  • age \> 18 years and informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phramonkutklao Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

IvabradineMetoprolol

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Purich - Surunchupakorn, M.D.

    Phramongkutklao College of Medicine and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Purich Surunchupakorn, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Col. Suthee Panichkul

Study Record Dates

First Submitted

December 19, 2012

First Posted

December 24, 2012

Study Start

December 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations