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This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anplag Tab. 100mg bid | Experimental | sarpogrelate hydrochloride 100mg bid for 24 weeks |
|
| Anplag Tab. 100mg tid | Experimental | sarpogrelate hydrochloride 100mg tid for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anplag Tab. 100mg bid | Drug | sarpogrelate hydrochloride 100mg bid for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 24 in tissue oxygen delivery index (tODI) | baseline, week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 12 in tODI | baseline, week 12 | |
| Proportion of subjects with tODI elevated by 20% or more | baseline, week 12, week 24 | |
| Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36) |
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Inclusion Criteria:
Exclusion Criteria:
Patients requiring acute or two or more antiplatelet agents
Patients requiring anticoagulant therapy
Patients requiring surgical procedure due to vascular occlusion
Patients whose results are confirmed at the screening as follows:
Patients with a history of cerebrovascular and cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, percutaneous coronary intervention) within the last 6 months
Contraindications stated in the SPC of sarpogrelate
Patients who are pregnant or planning to become pregnant
Those participating in other clinical trials with administration of investigational products at the screening
Those who are deemed to be ineligible to participate in the trial by investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital | Uijeongbu-si | Gyeonggido | South Korea |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
| C064294 | sarpogrelate |
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| Anplag Tab. 100mg tid | Drug | sarpogrelate hydrochloride 100mg tid for 24 weeks |
|
|
| baseline, week 24 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |