KCT0006237
Not Yet Recruiting
N/A
A Phase 4, Randomized, Open, Phase 4 Study to Evaluate the Efficacy of Sarpogrelate versus Cilostazol in patients with type2 diabetes with thickened carotid artery
The Catholic University of Korea, Bucheon St. Mary's Hospital0 sites128 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Catholic University of Korea, Bucheon St. Mary's Hospital
- Enrollment
- 128
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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