Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a single-arm, phase IV trial, of apixaban as treatment of venous thrombosis in patients with cancer. The current standard treatment of venous thrombosis in cancer patients is subcutaneous injections with low molecular weight heparin. During the last 5 years several new direct acting oral anticoagulants have been tested out as treatment of venous thrombosis. But very few cancer patients were included in the phase III clinical trials of the direct acting oral anticoagulants. Thus, there is a lack of information on how cancer patients with venous thrombosis will respond to treatment with direct acting oral anticoagulants. The current study will investigate the direct acting oral anticoagulant apixaban in cancer patients with venous thrombosis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Experimental | Apixaban 10 mg two times daily for 1 week, then apixaban 5mg two times daily for 6 months, then apixaban 2.5 mg two times daily for as long as the treating physician finds it necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis | 6 months after inclusion | |
| Major or clinically relevant non-major bleeding | 6 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 6 months after inclusion | |
| All cause mortality | 24 months after inclusion | |
| Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anders EA Dahm, MD, PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Norway | ||||
| Vestre Viken- Drammen Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37327527 | Derived | Larsen TL, Svalastoga M, Brekke J, Enden T, Froen H, Garresori H, Jacobsen EM, Paulsen PQ, Porojnicu AC, Ree AH, Torfoss D, Velle EO, Wik HS, Ghanima W, Sandset PM, Dahm AEA. Arterial events in cancer patients treated with apixaban for venous thrombosis. Thromb Res. 2023 Aug;228:128-133. doi: 10.1016/j.thromres.2023.05.017. Epub 2023 May 25. | |
| 32919178 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C522181 | apixaban |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 months after inclusion |
| Major or clinically relevant non-major bleeding | 24 months after inclusion |
| Drammen |
| Norway |
| Vestre Viken - Bærum sykehus | Gjettum | 1346 | Norway |
| Department of Hematology, Akershus University Hospital | Lørenskog | 1478 | Norway |
| Oslo University Hospital | Oslo | Norway |
| Østfold Hospital Kalnes | Sarpsborg | Norway |
| Stavanger University Hospital | Stavanger | Norway |
| St. Olavs Hospital | Trondheim | Norway |
| Volda Hospital | Volda | Norway |
| Hannevik TL, Brekke J, Enden T, Froen H, Garresori H, Jacobsen EM, Paulsen PQ, Porojnicu AC, Ree AH, Torfoss D, Velle EO, Wik HS, Ghanima W, Sandset PM, Dahm AEA. Thrombosis and bleedings in a cohort of cancer patients treated with apixaban for venous thromboembolism. Thromb Res. 2020 Dec;196:238-244. doi: 10.1016/j.thromres.2020.08.042. Epub 2020 Aug 28. |