Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism
Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism
Brief Summary:
This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism. Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks off and moves through the bloodstream. Patients with cancer are at increased risk for venous thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin is more effective in reducing blood clots in patients with cancer related venous thromboembolism.
Detailed Description:
PRIMARY OBJECTIVES:
I. Any episode of major bleeding including fatal bleeding.
SECONDARY OBJECTIVES:
I. Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary embolism (PE), fatal PE, or arterial thromboembolism.
II. Any episode of major bleeding including fatal bleeding or any episode of clinically relevant non-major bleeding.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive apixaban 10 mg orally (PO) twice daily (BID) on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.
ARM II: Patients receive dalteparin 200 international units (IU)/kg/day subcutaneously (SC) once daily (QD) on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
After completion of study treatment, patients are followed up at 3 months.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism
Actual Study Start Date: November 20, 2015
Actual Primary Completion Date: April 2, 2018
Actual Study Completion Date: December 24, 2019
Arms:
- Experimental: Arm I (apixaban)
- Experimental: Arm II (dalteparin)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 300 |
| Study start date | 20 November 2015 |
| Actual study completion date | 24 December 2019 |