NCT02585713

Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism

A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. ADAM-VTE

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.

Conditions

• Cerebral Vein Thrombosis
• Deep Vein Thrombosis
• Gonadal Thrombosis
• Hepatic Thrombosis
• Malignant Neoplasm
• Mesenteric Thrombosis
• Metastatic Malignant Neoplasm
• Portal Vein Thrombosis
• Pulmonary Embolism
• Renal Vein Thrombosis
• Splenic Thrombosis
• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Apixaban	Given PO
DRUG	Dalteparin	Given SC
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-11-20
• Primary completion: 2018-04-02
• Completion: 2019-12-24
• First posted: 2015-10-23
• Last updated: 2020-08-04
• Results posted: 2019-12-24

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study