Venous ThromboembolismPhase 2AVERTNCT02048865
Apixaban for the Prevention of Venous Thromboembolism in Cancer Patients
A Phase 2 study testing Apixaban in people with Venous Thromboembolism and Cancer, run by Ottawa Hospital Research Institute at 14 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Cancer
- What is being tested?
- Apixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 575 participants
- Where
- 14 sitesCanada
- Study dates
- 24 Mar 2014to 19 Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
Royal Victoria Regional Health Centre (RVH)
Barrie, Ontario, L4M 6M2
William Osler Health System -Brampton
Brampton, Ontario, L6R 3J7
Centre intégré de santé et de services sociaux de l'Outaouais - Gatineau
Gatineau, Quebec, J8P 7H2
Capital District Health Authority
Halifax, Nova Scotia, B3H 1V7
Juravinski Hospital & Cancer Centre
Hamilton, Ontario, L8V 1C3
Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences Center
London, Ontario, N6A 5W9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Lakeridge Health -Oshawa
Oshawa, Ontario
Ottawa Hospital-General Campus
Ottawa, Ontario, K1H 8L6
Centre intégré de santé et de services sociaux du Bas St Laurent -Rimouski
Rimouski, Quebec
Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8
Markham Stouffville Hospital
Toronto, Ontario, L3P 7P3
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients: A Randomized Placebo-Controlled, Double-Blind Clinical Trial
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.
Read the 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
- Blood Coagul Fibrinolysis 2011. Blood Coagul Fibrinolysis 2011;22:86-91.
- Blood 2010. Blood 2010;116:5377-5382.
- Blood 2008. Blood 2008;111:4902-4907.
- Conditions
- Venous Thromboembolism, Cancer
- Being tested
- Apixaban, Placebo drug
- Keywords
- VTE Cancer
- Medical subject headings
- Venous Thromboembolism, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
Apixaban 2.5 mg tablets BID for 6 months
Placebo drugDrug
placebo drug 2.5mg BID for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Active comparator | 2.5 mg BID for 6 months Receives: Drug: Apixaban |
| Placebo drug | Placebo comparator | 2.5 mg BID for 6 months Receives: Drug: Placebo drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE)
Measured: 7 months
Secondary outcomes (1)
Rate of adverse events
rate of clinical overt bleeding( major and minor bleeding) and death within the study period
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study start24 Mar 2014
- Primary completion10 Oct 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Phil Wells, MD, Principal investigator, Ottawa Hospital Research InstituteMarc Carrier, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048865
- Sponsor's protocol ID
- OHSN-20130563-01H
- Other IDs
- CV185-245
- Acronym
- AVERT
- Status last verified
- Nov 2018
- First submitted
- 27 Jan 2014
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35660801Wang 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.
PubMed 35124234Kahale 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.
PubMed 34622445Ladha 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.
PubMed 33857789Rutjes 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.
PubMed 33337539Carrier 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.
PubMed 30511879
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients: A Randomized Placebo-Controlled, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02048865
- Acronym / sponsor ID
- AVERT / OHSN-20130563-01H
- Conditions
- Venous Thromboembolism, Cancer
- Keywords
- VTE Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Bristol-Myers Squibb
- Study start
- 24 Mar 2014 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Blood Coagul Fibrinolysis 2011. Blood Coagul Fibrinolysis 2011;22:86-91.
- Blood 2010. Blood 2010;116:5377-5382.
- Blood 2008. Blood 2008;111:4902-4907.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Active comparator | Drug: Apixaban2.5 mg BID for 6 months |
| Placebo drug | Placebo comparator | Drug: Placebo drug2.5 mg BID for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: EliquisApixaban 2.5 mg tablets BID for 6 months | Drug | Apixaban |
| Placebo drugplacebo drug 2.5mg BID for 6 months | Drug | Placebo drug |
Primary outcome
first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE)
Time frame: 7 months
1 secondary outcome
Rate of adverse events
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 35660801Brandt 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.
- Derived from this study: PubMed 35124234Wang 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.
- Derived from this study: PubMed 34622445Kahale 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.
- Derived from this study: PubMed 33857789Ladha 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.
- Derived from this study: PubMed 33337539Rutjes 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.
- Derived from this study: PubMed 30511879Carrier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phil Wells, MD principal investigator
Ottawa Hospital Research Institute
Marc Carrier, MD principal investigator
Ottawa Hospital Research Institute
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apixaban in people with Venous Thromboembolism and Cancer, run by Ottawa Hospital Research Institute at 14 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048865, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.