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Apixaban for the Prevention of Venous Thromboembolism in Cancer Patients

NCT02048865 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 575

Last updated 2018-11-20

No results posted yet for this study

Summary

Cancer patients have an increased risk of developing blood clots in the veins compared to non-cancer patients. Cancer patients who develop blood clots can lead to reduced life expectancy, delayed cancer treatment, and decreased quality of life. Prevention is the most effective way to decrease the complications associated with blood clots in the veins. Although previous clinical trials have shown some benefit on the use of medication to prevent blood clots in the veins in ambulatory cancer patients, these studies have been inconclusive in demonstrating that existing blood thinners significantly reduce the rate of blood clots in cancer patients. One possible explanation relates to the fact that these studies have included a large proportion of cancer patients who are a low risk of developing blood clots in the veins. We are proposing to identify cancer patients who are at a high risk of developing blood clots by using a validated tool at the time of their cancer diagnosis. The identified high risk cancer patients will be asked to participate in a trial to test the safety and efficacy of a new oral medication that has been used to prevent blood clots in patients undergoing surgery. We are enrolling 574 patients in 7 Canadian centers (Ottawa, Halifax, Montreal, Vancouver, Sault Ste. Marie, Toronto and Hamilton). 287 patients will receive the study drug and 287 will receive an inactive substance. Analysis will be performed to assess the safety and the superiority of the study drug.

Conditions

  • Venous Thromboembolism
  • Cancer

Interventions

DRUG

Apixaban

Apixaban 2.5 mg tablets BID for 6 months

DRUG

Placebo drug

placebo drug 2.5mg BID for 6 months

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Phil Wells, MD · Ottawa Hospital Research Institute

  • Marc Carrier, MD · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-24
Primary Completion
2018-10-10
Completion
2018-10-19

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

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 NCT02048865 on ClinicalTrials.gov