Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With T2DM (ESCAPE)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilostazol
Aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cilostazol
Aspirin
Arm Description
Cilostazol 100-200 mg qd
Asprin 100mg qd for active comparator
Outcomes
Primary Outcome Measures
Coronary artery stenosis
Severity of coronary artery stenosis (%)
Secondary Outcome Measures
Plaque characteristics
Noncalified plaque
Plaque characteristics
Mixed plaque
Plaque characteristics
Calcified plaque
Multivessel involvement
Multivessel involvement in coronary arteries
Main vessel involvement
Left main and/or proximal LAD stenosis
Coronary artery calcium (CAC) score
Agatston score for CAC
Glucose homeostasis
Changes in HbA1c
Glucose homeostasis
Changes in fasting glucose concentration
Lipid metabolism
Changes in TG concentration
Lipid metabolism
Changes in HDL-concentration concentration
Full Information
NCT ID
NCT02266030
First Posted
October 11, 2014
Last Updated
October 5, 2017
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02266030
Brief Title
Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With T2DM
Acronym
ESCAPE
Official Title
Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cilostazol
Arm Type
Experimental
Arm Description
Cilostazol 100-200 mg qd
Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Asprin 100mg qd for active comparator
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
Pletaal
Intervention Description
Pletaal as an active drug
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin as an active comparator
Primary Outcome Measure Information:
Title
Coronary artery stenosis
Description
Severity of coronary artery stenosis (%)
Time Frame
one year
Secondary Outcome Measure Information:
Title
Plaque characteristics
Description
Noncalified plaque
Time Frame
one year
Title
Plaque characteristics
Description
Mixed plaque
Time Frame
one year
Title
Plaque characteristics
Description
Calcified plaque
Time Frame
one year
Title
Multivessel involvement
Description
Multivessel involvement in coronary arteries
Time Frame
one year
Title
Main vessel involvement
Description
Left main and/or proximal LAD stenosis
Time Frame
one year
Title
Coronary artery calcium (CAC) score
Description
Agatston score for CAC
Time Frame
one year
Title
Glucose homeostasis
Description
Changes in HbA1c
Time Frame
one year
Title
Glucose homeostasis
Description
Changes in fasting glucose concentration
Time Frame
one year
Title
Lipid metabolism
Description
Changes in TG concentration
Time Frame
one year
Title
Lipid metabolism
Description
Changes in HDL-concentration concentration
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Bleeding risk
Description
Any type of bleeding
Time Frame
one year
Title
Headache
Description
Any type of headache
Time Frame
one year
Title
Heart rate
Description
Frequence of heart beat per min
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD, PhD
Organizational Affiliation
SNUBH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Bundang-gu
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With T2DM
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