Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With T2DM

NCT02266030 | Completed Phase 3 DMC

• 1 other identifier: B-1010/114-005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective interventional study to assess the effect of cilostazol compared with aspirin in Korean T2DM patients with atherosclerosis.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Coronary artery stenosis

  Severity of coronary artery stenosis (%)

  one year

Secondary Outcomes (10)

• Plaque characteristics

  one year

• Plaque characteristics

  one year

• Plaque characteristics

  one year

• Multivessel involvement

  one year

• Main vessel involvement

  one year

Other Outcomes (3)

• Bleeding risk

  one year

• Headache

  one year

• Heart rate

  one year

Study Arms (2)

Cilostazol

EXPERIMENTAL

Cilostazol 100-200 mg qd

Drug: Cilostazol

Aspirin

ACTIVE COMPARATOR

Asprin 100mg qd for active comparator

Drug: Aspirin

Interventions

Cilostazol DRUG

Pletaal as an active drug

Also known as: Pletaal

Cilostazol

Aspirin DRUG

Aspirin as an active comparator

Aspirin

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes with HbA1c ≥ 6.0% at screening visit
• Male or female between 30 and 80 years of age
• Coronary artery stenosis: 25-75% without no evidence of acute coronary syndrome
• No history of previous myocardial infarction
• Estimated GFR ≥ 60 ml/min/1.73m²

You may not qualify if:

• SBP/DBP\> 160/110
• Congestive heart failure
• Allegy to radiocontrast dye
• Allegy to aspirin or cilostazol
• Acute bleeding
• History of ulcer bleeding
• GOT/GPT \> 100/100
• Other antiplatlet medication

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Bundang-gu, 463-707, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Cilostazol; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Soo Lim, MD, PhD

  SNUBH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2014
• First Posted: October 16, 2014
• Study Start: February 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

KR (1)