Comparison of Efficacy of Ivabradine Versus Metoprolol | NCT01755663

Studies
Comparison of Efficacy of Ivabradine Versus Metoprolol

NCT01755663

Sponsor

Col. Suthee Panichkul

Status

Unknown status

Last Update Posted

Oct 29, 2014Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Ivabradine and Metoprolol

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Dec 19, 2012

First Submission Date that Met QC Criteria

Dec 21, 2012

First Posted Date

Dec 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2014

Last Update Posted Date

Oct 29, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Col. Suthee Panichkul, Col. Suthee Panichkul, Phramongkutklao College of Medicine and HospitalSponsor-Investigator

Lead Sponsor

Col. Suthee PanichkulOTHER

Collaborators

Name	Class
Phramongkutklao College of Medicine and Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ivabradine and Metoprolol	Drug		Ivabradine metoprolol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart rate of patient before CT coronary		1 January 2013 to 31 december 2013

Secondary Outcomes

Measure	Description	Time Frame
safety and side effect of Metoprolol and Ivabradine		1 january 2013 to 31 december 2013

Other Outcomes

Measure	Description	Time Frame
Image quality		1 january 2013 to 31 december 2013

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Purich Surunchupakorn, M.D.	Contact	081-988-7390		winnermd57@gmail.com

Overall Officials

Name	Affiliation	Role
Purich - Surunchupakorn, M.D.	Phramongkutklao College of Medicine and Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phramonkutklao Hospital		Bangkok		10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077550	Ivabradine
D008790	Metoprolol

Ancestor Terms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided