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

February 7, 2018 updated by: Hyeon-Cheol Gwon, Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Hyoen-Cheol Gwon, MD,PhD
        • Contact:
          • Hyoen-Cheol Gwon, MD,PhD
          • Phone Number: 82-2-3410-3418
          • Email: hcgwon@skku.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Sarpogrelate versus placebo
Drug: Sarpogrelate
Sarpogrelate 100mg twice a day
Experimental: B
Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL > 130 mg/dl
Drug: Atorvastatin
Atorvastatin 80mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ergonovine provocation test 12months later
Time Frame: 1 year later
1 year later

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-12-069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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