Effect of Cilostazol on Coronary Artery Stenosis and Plaque Characteristics in Patients With T2DM
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Coronary Stenosis
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Cilostazol; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Pletaal as an active drug; Aspirin as an active comparator
Other intervention name(s): Pletaal
Intervention MeSH terms: Aspirin; Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment