Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer

NCT02744092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 811

Last updated 2023-10-03

Study results available
· View outcomes & findings →

Summary

The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.

Conditions

  • Cancer
  • Venous Thromboembolism
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Blood Clot

Interventions

DRUG

Rivaroxaban

Anticoagulation therapy.

DRUG

Apixaban

Anticoagulation therapy.

DRUG

Edoxaban

Anticoagulation therapy.

DRUG

Dabigatran

Anticoagulation therapy.

DRUG

Warfarin

Anticoagulation therapy.

DRUG

Dalteparin

Anticoagulation therapy.

DRUG

Enoxaparin

Anticoagulation therapy.

DRUG

Fondaparinux

Anticoagulation therapy.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • Alliance Foundation Trials, LLC.

    lead OTHER

Principal Investigators

  • Deborah Schrag, MD MPH · Alliance Foundation Trials, LLC.

  • Jean Connors, MD · Alliance Foundation Trials, LLC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-13
Primary Completion
2020-10-31
Completion
2021-02-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02744092 on ClinicalTrials.gov