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Purpose: Cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. With rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. Recent studies suggest that hypercoagulability is associated with poor prognosis and effective correction of coagulopathy maybe protective for survival in cancer related stroke patients. Optimal strategies to correct coagulopathy in cancer stroke patient remains to be determined. Currently, the use of low molecular-weighted heparin is recommended in these patients, but non-vitamin K oral anticoagulants (NOACs) could be safe alternative without the need for injection subcutaneously. Furthermore, NOACs could be an optimal treatment strategy for cancer-related stroke in terms of correcting coagulopathy with less injection related complication (ex. pain and infection) compared to Enoxaparin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edoxaban group | Experimental | Edoxaban, per oral, 60mg qd (may consider reduced dose to 30mg qd in patients with proper clinical reason by attending physician, estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine), for 90 days. |
|
| Enoxaparin group | Active Comparator | Enoxaparin, subcutaneous injection, 1mg/kg BID (may consider reduced dose to 1mg/kg qd in patients with proper clinical reason by attending physician, Creatinine clearance <30 mL/min), for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban | Drug | Edoxaban, per oral, 60mg qd (may consider reduced dose to 30mg qd in patients with proper clinical reason by attending physician, estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine), for 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| D-dimer change | interval change of serum D-dimer level between day 0 and 7 | 7 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Surrogate endpoint | number of micro-embolic signal detected by transcranial doppler | 7 days after treatment |
| Functional outcome | modified Rankin scale at 90 days, from 0 to 6, higher is worse |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38429253 | Derived | Chung JW, Hwang J, Kim HJ, Seo WK, Ahn MJ, Saver JL, Bang OY. Edoxaban for the treatment of hypercoagulability and cerebral thromboembolism associated with cancer: A randomized clinical trial of biomarker targets. Int J Stroke. 2024 Jul;19(6):645-653. doi: 10.1177/17474930241239266. Epub 2024 Mar 21. |
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|
| Enoxaparin | Drug | Enoxaparin, subcutaneous injection, 1mg/kg BID (may consider reduced dose to 1mg/kg qd in patients with proper clinical reason by attending physician, Creatinine clearance <30 mL/min), for 90 days. |
|
| 90 days after enrollment |
| Incidence of Treatment-Emergent Adverse Events [symptomatic intracerebral hemorrhage] | symptomatic intracerebral hemorrhage major bleeding all-cause death | 90 days after enrollment |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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