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Apixaban for Preventing Blood Clots in Cancer Patients

Phase 3
Waitlist Available
Led By Robert D McBane
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed acute index (original venous thrombotic) event: lower extremity or upper extremity (jugular, innominate, subclavian, axillary, brachial) DVT, PE, splanchnic (hepatic, portal, splenic, mesenteric, renal, gonadal), or cerebral vein thrombosis for which the patient has received >= 180 days (but =< 365 days) of anticoagulant therapy prior to registration; the date, imaging modality, and location of index event will be required; the date of initiation and specific type of anticoagulants used will also be required
Alanine aminotransferase (ALT) or aspartate transaminase (AST) =< 3 x upper limit of normal (ULN) obtained =< 30 days prior to registration
Must not have
Severe liver disease (known cirrhosis Childs Pugh class B or C), or active hepatitis
Gross hematuria at the time of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial studies the best dose of apixaban for preventing secondary cancer-related venous thrombosis in cancer patients who have completed anticoagulation therapy.

Who is the study for?
This trial is for cancer patients who've finished at least 6 months of blood clot treatment, have a life expectancy of over 6 months, and are in fairly good health. They must not be pregnant or nursing, agree to use contraception if necessary, and cannot have severe liver disease or recent bleeding issues.
What is being tested?
The study tests how well Apixaban works in preventing new blood clots after previous clot treatment in cancer patients. It's a phase III trial where the effectiveness and optimal dose of Apixaban will be determined by comparing it with other treatments.
What are the potential side effects?
Apixaban may cause bleeding problems including nosebleeds, heavier menstrual periods for women, bruising easily, persistent bleeding from cuts, pink or brown urine, red or black stools that look like tar.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had a blood clot in my leg, arm, or other areas and have been on blood thinners for 6 to 12 months.
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My liver enzymes are within the normal range.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe liver disease or active hepatitis.
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I am currently experiencing blood in my urine.
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I am currently experiencing significant bleeding.
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I am currently taking a blood thinner like clopidogrel and will continue on it.
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I have a bleeding disorder like hemophilia.
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I have been diagnosed with bacterial endocarditis.
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I had a blood clot despite being on blood thinners.
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I have not had major surgery within the last week.
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I am willing to use birth control during and after the treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CIF of Major or Clinically Relevant Non-major Bleeding Combined With Death as Competing Risk
Secondary study objectives
Cumulative Incidence Function of DVT/PE Treating Death or AE Resulting in End of Treatment as Competing Risk by Study Arm
Proportion of Patients Who Experienced at Least One Bleeding Event

Side effects data

From 2018 Phase 4 trial • 557 Patients • NCT01884337
7%
Incision site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
TOTAL KNEE REPLACEMENT (TKR)
TOTAL HIP REPLACEMENT (THR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group II (higher dose apixaban)Experimental Treatment1 Intervention
Patients receive higher dose apixaban PO BID for 365 days.
Group II: Group I (lower dose apixaban)Experimental Treatment1 Intervention
Patients receive lower dose apixaban PO BID for 365 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
2011
Completed Phase 4
~132290

Find a Location

Who is running the clinical trial?

Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
4,571 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
300 Patients Enrolled for Deep Vein Thrombosis
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,631 Total Patients Enrolled
3 Trials studying Deep Vein Thrombosis
430 Patients Enrolled for Deep Vein Thrombosis
Robert D McBanePrincipal InvestigatorAcademic and Community Cancer Research United
1 Previous Clinical Trials
5 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
5 Patients Enrolled for Deep Vein Thrombosis

Media Library

Apixaban Clinical Trial Eligibility Overview. Trial Name: NCT03080883 — Phase 3
Deep Vein Thrombosis Research Study Groups: Group I (lower dose apixaban), Group II (higher dose apixaban)
Deep Vein Thrombosis Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT03080883 — Phase 3
Apixaban 2023 Treatment Timeline for Medical Study. Trial Name: NCT03080883 — Phase 3
~44 spots leftby Nov 2025
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