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

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02266030
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
69
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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 CV 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 CV protection.

This is a prospective interventional study to assess the effect of cilostazol compared with aspirin in Korean T2DM patients with atherosclerosis. T2DM patients who have coronary artery stenosis by MDCT at least 3 months prior to this investigation will be enrolled.

Considering drop out due to adverse events or follow up loss, sufficient patients will be enrolled. Their medical record will be reviewed and relevant clinical and laboratory findings will be collected.

Cardiac computed tomography (CT) was introduced in the early 1990s. However, electron-beam CT (EBCT) only provided information on simple coronary artery calcium score (CAC). Recently, MDCT has been introduced, which can evaluate coronary arteries comprehensively. MDCT images can provide measurements of CAC, the degree of stenosis, and the characteristics of plaque including its potential vulnerability. These findings of MDCT have been reported to be in good agreement with intravascular ultrasound.

All scans are analyzed independently by two experienced investigators using a 3D workstation, who are blinded to the clinical information (Brilliance; Philips Medical Systems). After independent evaluations are made, a consensus interpretation is arrived at regarding the final MDCT diagnosis. Each lesion is identified using a multiplanar reconstruction technique and maximum intensity projection of the short axis, in two-chamber and four-chamber views. Image quality is evaluated on a per-segment basis and classified. Plaque characteristics on a per-segment basis are analyzed according to the modified American Heart Association classification.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With Type 2 Diabetes Mellitus
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cilostazol

Cilostazol 100-200 mg qd

Drug: Cilostazol
Pletaal as an active drug
Other Names:
  • Pletaal

    		•
    Active Comparator: Aspirin

    Asprin 100mg qd for active comparator

    Drug: Aspirin
    Aspirin as an active comparator

    Outcome Measures

    Primary Outcome Measures

    1. Coronary artery stenosis [one year]

      Severity of coronary artery stenosis (%)

    Secondary Outcome Measures

    1. Plaque characteristics [one year]

      Noncalified plaque

    2. Plaque characteristics [one year]

      Mixed plaque

    3. Plaque characteristics [one year]

      Calcified plaque

    4. Multivessel involvement [one year]

      Multivessel involvement in coronary arteries

    5. Main vessel involvement [one year]

      Left main and/or proximal LAD stenosis

    6. Coronary artery calcium (CAC) score [one year]

      Agatston score for CAC

    7. Glucose homeostasis [one year]

      Changes in HbA1c

    8. Glucose homeostasis [one year]

      Changes in fasting glucose concentration

    9. Lipid metabolism [one year]

      Changes in TG concentration

    10. Lipid metabolism [one year]

      Changes in HDL-concentration concentration

    Other Outcome Measures

    1. Bleeding risk [one year]

      Any type of bleeding

    2. Headache [one year]

      Any type of headache

    3. Heart rate [one year]

      Frequence of heart beat per min

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam Bundang-gu Korea, Republic of 463-707

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital

    Investigators

    • Principal Investigator: Soo Lim, MD, PhD, SNUBH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soo Lim, Professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT02266030
    Other Study ID Numbers:
    • B-1010/114-005
    First Posted:
    Oct 16, 2014
    Last Update Posted:
    Oct 9, 2017
    Last Verified:
    Oct 1, 2017
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Coronary Stenosis
    Aspirin
    Cilostazol

    Study Results

    No Results Posted as of Oct 9, 2017