NCT01674686

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.

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
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_4

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

Study Start

First participant enrolled

August 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

6.4 years

First QC Date

August 24, 2012

Last Update Submit

February 7, 2018

Conditions

Variant Angina

Keywords

VasospasmSarpogrelateStatin

Outcome Measures

Primary Outcomes (1)

  • Ergonovine provocation test 12months later

    1 year later

Secondary Outcomes (1)

  • C-reactive protein lever 12months later

    1 year

Study Arms (2)

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

SarpogrelateDRUG

Sarpogrelate 100mg twice a day

A
AtorvastatinDRUG

Atorvastatin 80mg daily

B

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyoen-Cheol Gwon, MD,PhD

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Angina Pectoris, Variant

Interventions

sarpogrelateAtorvastatin

Condition Hierarchy (Ancestors)

Angina, UnstableAngina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Central Study Contacts

Hyeon-Cheol Gwon, MD,PhD

CONTACT

82-2-3410-3419hcgwon@skku.edu

Jeong Hoon Yang, MD

CONTACT

82-2-3410-3419jhysmc@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 24, 2012

First Posted

August 29, 2012

Study Start

August 1, 2012

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

KR(1)