KCT0006237尚未招募未知
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 个研究点目标入组 128 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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