Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02266030
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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
Coronary Artery Disease Drug: Cilostazol Drug: Aspirin 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : February 2011
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cilostazol
Cilostazol 100-200 mg qd
Drug: Cilostazol
Pletaal as an active drug
Other Name: Pletaal

Active Comparator: Aspirin
Asprin 100mg qd for active comparator
Drug: Aspirin
Aspirin as an active comparator




Primary Outcome Measures :
  1. Coronary artery stenosis [ Time Frame: one year ]
    Severity of coronary artery stenosis (%)


Secondary Outcome Measures :
  1. Plaque characteristics [ Time Frame: one year ]
    Noncalified plaque

  2. Plaque characteristics [ Time Frame: one year ]
    Mixed plaque

  3. Plaque characteristics [ Time Frame: one year ]
    Calcified plaque

  4. Multivessel involvement [ Time Frame: one year ]
    Multivessel involvement in coronary arteries

  5. Main vessel involvement [ Time Frame: one year ]
    Left main and/or proximal LAD stenosis

  6. Coronary artery calcium (CAC) score [ Time Frame: one year ]
    Agatston score for CAC

  7. Glucose homeostasis [ Time Frame: one year ]
    Changes in HbA1c

  8. Glucose homeostasis [ Time Frame: one year ]
    Changes in fasting glucose concentration

  9. Lipid metabolism [ Time Frame: one year ]
    Changes in TG concentration

  10. Lipid metabolism [ Time Frame: one year ]
    Changes in HDL-concentration concentration


Other Outcome Measures:
  1. Bleeding risk [ Time Frame: one year ]
    Any type of bleeding

  2. Headache [ Time Frame: one year ]
    Any type of headache

  3. Heart rate [ Time Frame: one year ]
    Frequence of heart beat per min



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266030


Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Bundang-gu, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Layout table for investigator information
Principal Investigator: Soo Lim, MD, PhD SNUBH

Layout table for additonal information
Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02266030    
Other Study ID Numbers: B-1010/114-005
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents