Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery Disease

NCT ID: NCT02607436

Last Updated: 2016-05-03

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-04-30

Brief Summary

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

This is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic patients with atherosclerosis.

Detailed Description

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

Type 2 diabetes has been increased exponentially, arousing serious economic, social and health repercussions. Also, macrovascular complications of diabetes such as myocardial infarct or stroke have been increased. Individuals with diabetes have a greater risk of cardiovascular disease (CVD), approximately two to four times than that of those without diabetes. Currently, the U.S. Food and Drug Administration requires demonstration that new anti-hyperglycemic agents do not increase cardiovascular risk. The comprehensive and multifactorial management in type 2 diabetes, which includes control of hypertension, dyslipidemia and obesity, is known to significantly reduce the risk of CVD as shown in Steno-2 study. However, most anti-diabetic agents currently used in clinical practice do not seem to provide enough cardiovascular protection.

Conditions

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

Coronary Artery Disease

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Sarpogrelate + Aspirin

Sarpogrelate as an active drug

Group Type EXPERIMENTAL

Sarpogrelate

Intervention Type DRUG

Sarpogrelate

Aspirin

Intervention Type DRUG

Aspirin

Aspirin alone

Aspirin as an active comparator

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin

Interventions

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

Sarpogrelate

Sarpogrelate

Intervention Type DRUG

Aspirin

Aspirin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Anplag Aspirin protect or Astrix

Eligibility Criteria

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

Inclusion Criteria

* Type 2 diabetes with HbA1c ≥ 6.5% at screening visit
* Male or female between 30 and 80 years of age
* Coronary artery stenosis: 10-75% without no evidence of acute coronary syndrome
* No history of previous myocardial infarction

Exclusion Criteria

* Systolic blood pressure / diastolic blood pressure \> 160/110 mmHg
* Congestive heart failure
* Allergy to radiocontrast dye
* Allergy to aspirin or sarpogrelate
* Acute bleeding
* History of ulcer bleeding
* GOT/GPT \> 100/100
* Other antiplatelet medication
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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

Soo Lim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Soo Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

SNUBH

Locations

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

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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

South Korea

Other Identifiers

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

B-1111/139-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Aspirin Effectiveness Study
NCT01113060 UNKNOWN
Recurrent Carotid Stenosis
NCT00000527 COMPLETED PHASE2