NCT02048865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
575

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 24, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

4.6 years

First QC Date

January 27, 2014

Last Update Submit

November 19, 2018

Conditions

Venous ThromboembolismCancer

Keywords

VTE Cancer

Outcome Measures

Primary Outcomes (1)

  • first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE)

    7 months

Secondary Outcomes (1)

  • Rate of adverse events

    7 months

Study Arms (2)

Apixaban

ACTIVE COMPARATOR

2.5 mg BID for 6 months

Drug: Apixaban

Placebo drug

PLACEBO COMPARATOR

2.5 mg BID for 6 months

Drug: Placebo drug

Interventions

ApixabanDRUG

Apixaban 2.5 mg tablets BID for 6 months

Also known as: Eliquis
Apixaban
Placebo drugDRUG

placebo drug 2.5mg BID for 6 months

Placebo drug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Capital District Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Royal Victoria Regional Health Centre (RVH)

Barrie, Ontario, L4M 6M2, Canada

Location

William Osler Health System -Brampton

Brampton, Ontario, L6R 3J7, Canada

Location

Juravinski Hospital & Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

Lakeridge Health -Oshawa

Oshawa, Ontario, Canada

Location

Ottawa Hospital-General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Sault Area Hospital

Sault Ste. Marie, Ontario, P6B 0A8, Canada

Location

Markham Stouffville Hospital

Toronto, Ontario, L3P 7P3, Canada

Location

Centre intégré de santé et de services sociaux de l'Outaouais - Gatineau

Gatineau, Quebec, J8P 7H2, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Centre intégré de santé et de services sociaux du Bas St Laurent -Rimouski

Rimouski, Quebec, Canada

Location

Related Publications (6)

  • Brandt W, Brown C, Wang TF, Tagalakis V, Shivakumar S, Ciuffini LA, Mallick R, Wells PS, Carrier M. Efficacy and safety of apixaban for primary prevention of thromboembolism in patients with cancer and a central venous catheter: A subgroup analysis of the AVERT Trial. Thromb Res. 2022 Aug;216:8-10. doi: 10.1016/j.thromres.2022.05.014. Epub 2022 May 29.

    PMID: 35660801DERIVED

  • Wang TF, Mallick R, Carrier M, Wells PS. Safety and efficacy of apixaban thromboprophylaxis in ambulatory cancer patients according to renal function: A subgroup analysis of the AVERT trial. Thromb Res. 2022 Mar;211:85-87. doi: 10.1016/j.thromres.2022.01.022. Epub 2022 Jan 31.

    PMID: 35124234DERIVED

  • Kahale LA, Matar CF, Tsolakian I, Hakoum MB, Barba M, Yosuico VE, Terrenato I, Sperati F, Schunemann H, Akl EA. Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation. Cochrane Database Syst Rev. 2021 Oct 8;10(10):CD006466. doi: 10.1002/14651858.CD006466.pub7.

    PMID: 34622445DERIVED

  • Ladha D, Mallick R, Wang TF, Caiano L, Wells PS, Carrier M. Efficacy and safety of apixaban for primary prevention in gastrointestinal cancers: A post-hoc analysis of the AVERT trial. Thromb Res. 2021 Jun;202:151-154. doi: 10.1016/j.thromres.2021.03.013. Epub 2021 Mar 21.

    PMID: 33857789DERIVED

  • Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

    PMID: 33337539DERIVED

  • Carrier M, Abou-Nassar K, Mallick R, Tagalakis V, Shivakumar S, Schattner A, Kuruvilla P, Hill D, Spadafora S, Marquis K, Trinkaus M, Tomiak A, Lee AYY, Gross PL, Lazo-Langner A, El-Maraghi R, Goss G, Le Gal G, Stewart D, Ramsay T, Rodger M, Witham D, Wells PS; AVERT Investigators. Apixaban to Prevent Venous Thromboembolism in Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):711-719. doi: 10.1056/NEJMoa1814468. Epub 2018 Dec 4.

    PMID: 30511879DERIVED

MeSH Terms

Conditions

Venous ThromboembolismNeoplasms

Interventions

apixaban

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Phil Wells, MD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

  • Marc Carrier, MD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 29, 2014

Study Start

March 24, 2014

Primary Completion

October 10, 2018

Study Completion

October 19, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations

CA(14)