KCT0005088
Recruiting
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic diseases
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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