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

NCT ID: NCT01674686

Last Updated: 2018-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Variant Angina

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Sarpogrelate versus placebo

Group Type EXPERIMENTAL

Sarpogrelate

Intervention Type DRUG

Sarpogrelate 100mg twice a day

B

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

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Atorvastatin 80mg daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sarpogrelate

Sarpogrelate 100mg twice a day

Intervention Type DRUG

Atorvastatin

Atorvastatin 80mg daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hyeon-Cheol Gwon

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hyoen-Cheol Gwon, MD,PhD

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hyeon-Cheol Gwon, MD,PhD

Role: CONTACT

82-2-3410-3419

Jeong Hoon Yang, MD

Role: CONTACT

82-2-3410-3419

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hyoen-Cheol Gwon, MD,PhD

Role: primary

82-2-3410-3418

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-12-069

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.