Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation Therapy

Pulmonary Embolism Clinical Trial

Official title: A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy

Status Active, not recruiting

Clinical Trial Summary

This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related venous thrombosis in cancer patients who have completed anticoagulation therapy. Apixaban may help in prevention by blocking some of the enzymes needed for venous thrombosis.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. Any episode of major bleeding including fatal bleeding or clinically relevant non-major bleeding.

SECONDARY OBJECTIVES:

I. The proportion of patients who experienced at least one such bleeding event within 6 months of beginning treatment.

II. Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary embolism (PE), fatal PE, or arterial thromboembolism.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive lower dose apixaban orally (PO) twice daily (BID) for 365 days.

GROUP II: Patients receive higher dose apixaban PO BID for 365 days.

After completion of study treatment, patients are followed up for 30 days. ;

Related Conditions & MeSH terms

• Cerebral Vein Thrombosis
• Deep Vein Thrombosis
• Embolism
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Metastatic Malignant Solid Neoplasm
• Neoplasms
• Pulmonary Embolism
• Splanchnic Vein Thrombosis
• Thrombosis
• Venous Thrombosis

• NCT number: NCT03080883
• Study type: Interventional
• Source: Academic and Community Cancer Research United
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 14, 2017
• Completion date: May 31, 2025