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

Primary Purpose

Variant Angina

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sarpogrelate
Atorvastatin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Variant Angina focused on measuring Vasospasm, Sarpogrelate, Statin

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hyoen-Cheol Gwon, MD,PhDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Sarpogrelate versus placebo

Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL > 130 mg/dl

Outcomes

Primary Outcome Measures

Ergonovine provocation test 12months later

Secondary Outcome Measures

C-reactive protein lever 12months later

Full Information

First Posted
August 24, 2012
Last Updated
February 7, 2018
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01674686
Brief Title
The Effect of Sarpogrelate and High Dose Statin on the Reduction of Coronary Spasm
Official Title
A Prospective, Single-center, Randomized Study 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2012 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Variant Angina
Keywords
Vasospasm, Sarpogrelate, Statin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Sarpogrelate versus placebo
Arm Title
B
Arm Type
Experimental
Arm Description
Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL > 130 mg/dl
Intervention Type
Drug
Intervention Name(s)
Sarpogrelate
Intervention Description
Sarpogrelate 100mg twice a day
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 80mg daily
Primary Outcome Measure Information:
Title
Ergonovine provocation test 12months later
Time Frame
1 year later
Secondary Outcome Measure Information:
Title
C-reactive protein lever 12months later
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyeon-Cheol Gwon, MD,PhD
Phone
82-2-3410-3419
Email
hcgwon@skku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Hoon Yang, MD
Phone
82-2-3410-3419
Email
jhysmc@gmail.com
Facility Information:
Facility Name
Hyoen-Cheol Gwon, MD,PhD
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoen-Cheol Gwon, MD,PhD
Phone
82-2-3410-3418
Email
hcgwon@skku.edu

12. IPD Sharing Statement

Learn more about this trial

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

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