Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02048865
Previous Study | Return to List | Next Study

Apixaban for the Prevention of Venous Thromboembolism in Cancer Patients (AVERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02048865
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Cancer Drug: Apixaban Drug: Placebo drug Phase 2

Detailed Description:

Patients holding a malignancy have a 7 to 28-fold higher risk for venous thromboembolism (VTE) than non-cancer patients(1). Since most cancer patients are currently treated in the outpatient setting, an acute episode of VTE has important implications on their care due to its effects on reduced life expectancy, high rates of VTE recurrence, therapeutic failures, delays in chemotherapy and the risk of bleeding during anticoagulation.

The best treatment of an acute episode of VTE is its prevention (thromboprophylaxis). Although previous clinical trials have shown some benefit on the use of thromboprophylaxis in ambulatory cancer patients, these studies have been inconclusive to convincingly demonstrate that existing anticoagulants significantly reduce the rate of VTE in cancer patients. Possible explanations are related to the fact that these studies have included a large number of cancer patients whose risk for VTE has been low and in consequence, the benefit of anticoagulation has become diluted by the large proportion of low risk cancer patients.

To increase the success of thromboprophylaxis in cancer outpatients, we propose, first, to include validated methods for predicting the risk of VTE at the time of cancer diagnosis(2, 3). This strategy will facilitate to identify cancer patients at high-risk for VTE and then, optimize the risk-to benefit ratio with anticoagulation. Second, to assess safety and efficacy of new oral anticoagulants in cancer patients as they represent an attractive alternative for an extended use of thromboprophylaxis. As a choice, new oral agents can be administered in fixed doses, do not require laboratory monitoring, have minimal interaction with additional drugs and provide a pain free alternative in patients who require injections.

Reference List

  1. Blood Coagul Fibrinolysis 2011. Blood Coagul Fibrinolysis 2011;22:86-91.
  2. Blood 2010. Blood 2010;116:5377-5382.
  3. Blood 2008. Blood 2008;111:4902-4907.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 575 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients: A Randomized Placebo-Controlled, Double-Blind Clinical Trial
Actual Study Start Date : March 24, 2014
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : October 19, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Active Comparator: Apixaban
2.5 mg BID for 6 months
Drug: Apixaban
Apixaban 2.5 mg tablets BID for 6 months
Other Name: Eliquis

Placebo Comparator: Placebo drug
2.5 mg BID for 6 months
Drug: Placebo drug
placebo drug 2.5mg BID for 6 months




Primary Outcome Measures :
  1. first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Rate of adverse events [ Time Frame: 7 months ]
    rate of clinical overt bleeding( major and minor bleeding) and death within the study period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A newly diagnosed cancer site or progression of the malignant disease after complete or partial remission.
  • Initiating a new course of chemotherapy with a minimum intent of 3 months therapy
  • A VTE risk stratification score of ≥ 2, according to the scoring method
  • Age 18 years old or older
  • Provide written informed consent

Exclusion Criteria:

  • Lesions or conditions at increased risk of clinically significant bleeding (eg. active peptic ulcer disease)
  • Objectively confirmed substantial liver insufficiency as defined by clinical manifestations of ascites, cirrhosis, encephalopathy and/or jaundice and/or biochemical abnormalities in liver function tests including hypoalbuminemia (< 3.5 gr/dL), elevated levels of total bilirubin (> 25 umol/L), elevated liver transaminases (2 times the upper limit of normal) and/or biochemical diagnosis of biliary tract obstruction (elevated levels of gamma-glutamyl transferase and alkaline phosphatase, 3 times the upper limit of normal). *
  • Diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome**
  • Planned stem cell transplant
  • Life expectancy less than 6 months
  • Acute or chronic renal insufficiency with glomerular filtration rate (GFR) < 30 ml/min calculated by the Cockroft and Gault formula.
  • Pregnancy***
  • Continuous anticoagulation with vitamin K antagonists, low-molecular-weight heparin (LMWH), or other oral anticoagulants
  • Weight < 40 Kg
  • Platelet count < 50 x 109/L
  • Known allergies to ingredients contained in apixaban
  • Use of any contraindicated medications with apixaban

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048865


Locations
Layout table for location information
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Royal Victoria Regional Health Centre (RVH)
Barrie, Ontario, Canada, L4M 6M2
William Osler Health System -Brampton
Brampton, Ontario, Canada, L6R 3J7
Juravinski Hospital & Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
London Health Sciences Center
London, Ontario, Canada, N6A 5W9
Lakeridge Health -Oshawa
Oshawa, Ontario, Canada
Ottawa Hospital-General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada, P6B 0A8
Markham Stouffville Hospital
Toronto, Ontario, Canada, L3P 7P3
Canada, Quebec
Centre intégré de santé et de services sociaux de l'Outaouais - Gatineau
Gatineau, Quebec, Canada, J8P 7H2
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Centre intégré de santé et de services sociaux du Bas St Laurent -Rimouski
Rimouski, Quebec, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Principal Investigator: Phil Wells, MD Ottawa Hospital Research Institute
Principal Investigator: Marc Carrier, MD Ottawa Hospital Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02048865     History of Changes
Other Study ID Numbers: OHSN-20130563-01H
CV185-245 ( Other Grant/Funding Number: Bristol-Myers Squibb )
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Keywords provided by Ottawa Hospital Research Institute:
VTE Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants