Effects of Sarpogrelate sustained-release treatment on improvement of ischemic symptoms and hematologic changes (whole blood viscosity changes) in patients with type 2 diabetic peripheral vascular disease, Single-center, randomized, open, Parallel,Phase 4 clinical trial

Seoul National University Bundang Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新: 2022年11月28日

适应症

试验速览

暂无简介。

•1. Adults aged = 19 years ~ < 80 years
•2. Patients with diabetic peripheral vascular disease who are administered Anplone® SR 300 mg (Sarpogrelate HCl) and aspirin
•3. Those who are ABI(ankle brachial pressure index test) 0.9 within 1 year
•4. Those with type 2 diabetes who have clinical pain (ischemic symptom of chronic arterial occlusion) evaluation result 30 mm or more (100 mm Pain VAS) at visit 2
•5. Those who have not changed any other concomitant drugs (antihypertensives, insulin), including oral hypoglycemic agents within 3 months
•6. Those with HbA1c (glycosylated hemoglobin) less than 10%
•7. Those who voluntarily sign a written consent and agree to participate in the study

•1) Those who have bleeding within one week of participating in the study
•2) Those who have a disease (hemophilia, capillary fragility, gastrointestinal ulcer, urinary bleeding, hemoptysis, vitreous hemorrhage, etc.) that may increase bleeding during study participation
•3) Patients with cerebrovascular and cardiovascular complications within 6 months (Cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass graft, PCI)
•4) Patients with severe renal or hepatic disease
•5) Female patients who are or may be pregnant
•6) Female patients who are or will be breastfeeding at the time of study participation

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