The Effect of Sarpogrelate and High Dose Statin on the Re... | NCT01674686

Studies
The Effect of Sarpogrelate and High Dose Statin on the Reduction of Coronary Spasm

NCT01674686

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Feb 9, 2018Actual

Enrollment

200Estimated

Phase

Phase 4

Conditions

Variant Angina

Interventions

Sarpogrelate
Atorvastatin

Countries

South Korea

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2012Actual

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Aug 24, 2012

First Submission Date that Met QC Criteria

Aug 28, 2012

First Posted Date

Aug 29, 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

Feb 7, 2018

Last Update Posted Date

Feb 9, 2018Actual

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

Description Module

Brief Summary

The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients with variant angina.

Detailed Description

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Sarpogrelate versus placebo	Drug: Sarpogrelate
B	Experimental	Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL > 130 mg/dl	Drug: Atorvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sarpogrelate	Drug	Sarpogrelate 100mg twice a day	A
Atorvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ergonovine provocation test 12months later		1 year later

Secondary Outcomes

Measure	Description	Time Frame
C-reactive protein lever 12months later		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical history of chest pain compatible with variant angina; morning chest pain aggravated by cold exposure.
Angiographically proven coronary spasm; TIMI flow < 3 by spontaneous coronary spasm or intracoronary ergonovine spasm provocation test.

Exclusion Criteria:

Cardiac arrest by coronary spasm
Left main coronary spasm
Significant fixed coronary artery stenosis; Diameter stenosis > 70% in the major epicardial artery by coronary angiography
Left ventricular ejection fraction < 30%
Coagulation disorders or bleeding tendency (Platelet count < 50k, PT INR > 2.0)
Significant liver disease (AST or ALT > 100 U/ml)
Renal failure (S-Cr > 2.0 mg/dl)
hypersensitivity for statin
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyeon-Cheol Gwon, MD,PhD	Contact	82-2-3410-3419		hcgwon@skku.edu
Jeong Hoon Yang, MD	Contact	82-2-3410-3419		jhysmc@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hyoen-Cheol Gwon, MD,PhD	Recruiting	Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000788	Angina Pectoris, Variant

Ancestor Terms

ID	Term
D000789	Angina, Unstable
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C064294	sarpogrelate
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided