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

NCT02585713 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-08-04

Study results available
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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

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

DRUG

Apixaban

Given PO

DRUG

Dalteparin

Given SC

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Academic and Community Cancer Research United

    lead OTHER

Principal Investigators

  • Robert McBane · Academic and Community Cancer Research United

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-20
Primary Completion
2018-04-02
Completion
2019-12-24
FDA Drug
Yes

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 NCT02585713 on ClinicalTrials.gov