A study for comparative evaluation of the effect of drug administration on carotid thickness in patients with thickened carotid type 2 diabetes
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0006237
- Lead Sponsor
- The Catholic University of Korea, Bucheon St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 128
1. Adult men and women over 19 years of age
2. Patients with type 2 diabetes who meet at least one below standard of carotid ultrasound conducted at the time of screening and require administration of antiplatelet preparation
- Carotid Intima-Media Thickness (IMT) greater than 1.0 mm
- 1 or more Plaque*
* Plaque criteria: According to Mannheim Carotid Intima-Media Thickness Consensus, if any of the following three:
? In case of partial invasion of at least 0.5mm with arterial lumen
? 50% or more increase in ambient IMT thickness
? If the thickness is 1.5mm or higher
3. A person who understands the purpose and contents of this clinical trial, the characteristics and risks of the investigational product, and gives written consent after hearing the full explanation
1. Patients administered antiplatelet or anticoagulant within 12 weeks prior to randomization
2. Patients with any prohibition of administration of Sarpogrelate or Cilostazol
- a person who has bleeding (hemophilia, capillary brittleness, digestive tract ulcer, urinary bleeding, hemoptysis, vitreous hemorrhage), or hemorrhagic factor(active peptic ulcer, hemorrhagic stroke within the last 6 months, surgical surgery within 3 months, , proliferative diabetic retinopathy, uncontrolled hypertension)
- Congestive heart failure
- A person who has a history of hypersensitivity to Sarpogrelate or Cilostazol
3. Patients with 9.0% or more of Hb1Ac examinations conducted at the time of screening
4. Patients with prohibitions specified in the Sarpogrelate SR or Cilostazol SR permits at the time of screening, or any of the following laboratory test results have been confirmed
- Patients with severe nephropathy (Estimated GFR (MDRD) < 30 mL/min/1.73 m2)
- Those with active liver disease or more than 3 times the normal upper limit (UNL) of ALT or AST
5. Pregnant women or lactating people
6. Persons participating in clinical trials of other medications
7. In addition to the above, a person who determines that the investigator is unfit to participate in this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Intima-Media Thickness (IMT) change in the Common Carotid Artery (CCA) identified by ultrasound at 48 weeks compared to baseline
- Secondary Outcome Measures
Name Time Method Changes in the Mean Intima-Media Thickness (IMT) of the Common Carotid Artery (CCA) at 48 weeks compared to baseline;Variation in the number of carotid plaques at 48 weeks from the base point;Maximum thickness change of carotid Plaque at 48 weeks compared to base point;Lipid Profile (TC, LDL-C, HDL-C, TG) changes from base point to base point 48 weeks;HbA1c change at 48 weeks compared to base point