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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I've had a blood clot in my leg, arm, or other areas and have been on blood thinners for 6 to 12 months.
Select...
My liver enzymes are within the normal range.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CIF of Major or Clinically Relevant Non-major Bleeding Combined With Death as Competing Risk
Secondary outcome measures
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 • NCT018843377%
Incision site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
TOTAL KNEE REPLACEMENT (TKR)
TOTAL HIP REPLACEMENT (THR)
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
4,766 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
300 Patients Enrolled for Deep Vein Thrombosis
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,783 Total Patients Enrolled
2 Trials studying Deep Vein Thrombosis
400 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine clearance, is adequate.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study. If you have had your period and are not in menopause or sterilized, you are considered able to become pregnant.I have active cancer, confirmed by scans or treatment in the last 6 months.You have had a serious allergic reaction to apixaban.You had bleeding inside your eye within the last 6 months before the study starts.I have severe liver disease or active hepatitis.I have not had a stomach bleed or ulcer in the last 6 months.I am currently experiencing blood in my urine.I've had a blood clot in my leg, arm, or other areas and have been on blood thinners for 6 to 12 months.Your platelet count is at least 50,000 per cubic millimeter within 30 days before joining the study.I am currently experiencing significant bleeding.I have not had a brain bleed in the last 6 months.My liver enzymes are within the normal range.I agree to use effective birth control during and after the study.I am not currently using strong CYP3A4 drugs, or I can switch or stop them if needed.I am currently taking a blood thinner like clopidogrel and will continue on it.I have a bleeding disorder like hemophilia.I have been diagnosed with bacterial endocarditis.I am willing to have monthly check-ups in person or by phone.I have not had a serious head injury in the last month.Women who are currently breastfeeding.You have a mechanical heart valve.I had a blood clot despite being on blood thinners.I have not had major surgery within the last week.I had brain surgery less than 2 weeks ago.I am willing to use birth control during and after the treatment.I can take care of myself but might not be able to do heavy physical work.You are expected to live for at least 6 more months.Your hemoglobin level needs to be at least 8 grams per deciliter within the 30 days before you join the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (lower dose apixaban)
- Group 2: Group II (higher dose apixaban)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the Apixaban drug's official standing with the FDA?
"There is some evidence of Apixaban's efficacy and it has undergone multiple rounds of testing, so it received a score of 3 for safety."
Answered by AI
Are we currently enrolling people for this experiment?
"This study is not looking for participants at this moment. The listing was created on July 14th, 2017 and last updated on June 30th, 2022. If you are interested in other studies, there are 2721 trials actively recruiting patients with pulmonary embolism and 50 trials using Apixaban currently seeking candidates."
Answered by AI
In how many different hospitals is this trial taking place?
"In addition to the Dartmouth Hitchcock Medical Center in Lebanon, New hampshire, and the University of Washington Medical Center in Seattle, Washington, this study is also running out of 33 other locations including the Metro Minnesota Community Oncology Research Consortium in Saint Louis Park, Minnesota."
Answered by AI
Is this the first time Apixaban has been used in a research setting?
"The first clinical trial for apixaban was conducted in 2015 at the Juan Ramon Jimenez Hospital. As of now, there are 121 completed studies and 50 active trials. A large portion of these ongoing studies are based in Lebanon, New hampshire."
Answered by AI
What are the approved medical uses for Apixaban?
"Apixaban has shown efficacy in the treatment of atrial fibrillation, deep vein thrombosis, and disease."
Answered by AI
How many individuals are included in this clinical trial?
"Unfortunately, this specific study is no longer recruiting patients. It was initially posted on July 14th 2017 and updated as recently as June 30th of this year. If you are interested in other studies, there are 2721 trials for pulmonary embolism and 50 Apixaban studies still admitting patients."
Answered by AI
Is this a ground-breaking clinical trial?
"Apixaban has been available for clinical study since 2015. After the first trial, which was run by Pfizer and completed in 2015 with 4012 participants, Apixaban received its Phase 4 drug approval. At present, there are 50 active trials taking place in 380 cities across 35 countries."
Answered by AI
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