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Anticoagulant
Apixaban for Cancer-Associated Thrombosis (API-CAT Trial)
Phase 3
Waitlist Available
Research Sponsored by Assistance Publique - Hôpitaux de Paris
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any cancer diagnosed histologically (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intra-cerebral metastasis)
Active cancer defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy, hormonotherapy, targeted therapy, immunotherapy at inclusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the treatment period (12 months)
Awards & highlights
API-CAT Trial Summary
This trialwill compare a low vs. full dose of Apixaban for preventing recurrent VTE in patients with cancer who have had 6+ months of anticoagulant therapy.
Who is the study for?
This trial is for adults with active cancer who've had a blood clot in the lung or leg and have been on blood thinners for at least 6 months. They should not be pregnant, breastfeeding, or have a life expectancy less than 12 months. People with certain bleeding risks, severe liver issues, very low platelets, or those on specific other medications are excluded.Check my eligibility
What is being tested?
The study tests if a lower dose of Apixaban (2.5 mg twice daily) is as effective as the full dose (5 mg twice daily) in preventing new clots after initial treatment in patients with cancer-related thrombosis.See study design
What are the potential side effects?
Apixaban can cause bleeding problems which might lead to serious or fatal outcomes. It may also cause allergic reactions, liver enzyme changes, and anemia.
API-CAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a cancer diagnosis confirmed by tissue examination, excluding certain skin cancers, primary brain tumors, or brain metastases.
Select...
I am currently receiving or planning to receive treatment for my active cancer.
Select...
I am expected to be on blood thinners for at least 12 months.
Select...
My deep vein thrombosis (DVT) is located above my knee and confirmed by an imaging test.
Select...
My tests show a blood clot in my lung.
Select...
I have had a blood clot in my leg, pelvis, or lung.
Select...
I have a blood clot in my leg or lung found by accident during other medical scans.
Select...
I've been on blood thinner medication for over 6 months after my clotting event.
Select...
I haven't had symptoms of a blood clot since my first one.
API-CAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the treatment period (12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the treatment period (12 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The incidence of an an adjudicated composite endpoint
Secondary outcome measures
Adjudicated composite of recurrent symptomatic VTE, VTE related-death, all-cause death, adjudicated major bleeding.
Adjudicated major bleeding.
All-cause death
+3 moreAPI-CAT Trial Design
2Treatment groups
Active Control
Group I: Apixaban film coated tablets 2.5 mgActive Control1 Intervention
Patients randomized in the apixaban reduced dose group will receive an apixaban 2.5 mg tablet and a placebo of apixaban 5 mg tablet, twice daily for 12 months.
Group II: Apixaban film coated tablets 5 mgActive Control1 Intervention
Patients randomized in the apixaban full dose group will receive a placebo of apixaban 2.5 mg tablet and an apixaban 5 mg tablet, twice daily for 12 months.
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Who is running the clinical trial?
Assistance Publique - Hôpitaux de ParisLead Sponsor
3,134 Previous Clinical Trials
56,876,828 Total Patients Enrolled
16 Trials studying Thrombosis
6,247 Patients Enrolled for Thrombosis
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,126,747 Total Patients Enrolled
40 Trials studying Thrombosis
47,419 Patients Enrolled for Thrombosis
Guy Meyer, PrStudy DirectorAPHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
1 Previous Clinical Trials
302 Total Patients Enrolled
1 Trials studying Thrombosis
302 Patients Enrolled for Thrombosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your platelet count is less than 75,000 per cubic millimeter.I am not pregnant or breastfeeding.You have a blood clot in your catheter.You are not expected to live for more than 12 months.Your blood pressure is too high and not well controlled, with the top number higher than 180 or the bottom number higher than 110.You are being held against your will for treatment of a mental or physical illness.My blood clot symptoms returned while I was on blood thinners.Your hemoglobin level is less than 8 grams per deciliter.I have a blood clot in my arm or near my heart.I am on long-term blood thinners.I haven't had serious bleeding or major surgery recently.I have been diagnosed with bacterial endocarditis.I am not in a drug trial that affects blood clotting.I have a cancer diagnosis confirmed by tissue examination, excluding certain skin cancers, primary brain tumors, or brain metastases.I am not using or cannot use birth control methods to prevent pregnancy during the study.I have a blood clot in the lower part of my leg.I have significant difficulty with self-care or am completely disabled.My kidney function is reduced with a creatinine clearance below 30 ml/min.I do not have severe liver issues or significantly high liver enzyme levels.I need long-term blood thinner treatment due to a mechanical heart valve or antiphospholipid syndrome.I am currently receiving or planning to receive treatment for my active cancer.I am expected to be on blood thinners for at least 12 months.I need more than 165 mg/day of aspirin or am on blood thinner medication.I am on or can switch to single anti-platelet therapy before the trial starts.I am not taking strong medication that affects liver enzymes or drug transporters.I am younger than 18 years old.My deep vein thrombosis (DVT) is located above my knee and confirmed by an imaging test.My tests show a blood clot in my lung.I have had a blood clot in my leg, pelvis, or lung.I have a blood clot in my leg or lung found by accident during other medical scans.I've been on blood thinner medication for over 6 months after my clotting event.You are allergic to apixaban.I have a small, possibly accidental blood clot in my lungs without any in my legs.I haven't had symptoms of a blood clot since my first one.I had a blood clot while on a full-dose blood thinner.I am not pregnant.I have a blood clot in an organ.
Research Study Groups:
This trial has the following groups:- Group 1: Apixaban film coated tablets 2.5 mg
- Group 2: Apixaban film coated tablets 5 mg
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many individuals have been accepted into this trial thus far?
"Affirmative. Clinicaltrials.gov data indicates that this research trial is actively looking for participants, with a total of 1722 individuals sought from 5 distinct medical facilities. It was initially posted on October 11th 2018 and the most recent alteration took place on December 7th 2022 ."
Answered by AI
Is this research study currently enrolling participants?
"The information accessible on clinicaltrials.gov confirms that this medical trial, which was unveiled on October 11th 2018, is still recruiting patients. It was last amended on December 7th 2022."
Answered by AI
What medical purpose does Apixaban film coated tablets 2.5 mg typically serve?
"Apixaban film coated tablets 2.5 mg is commonly prescribed for atrial fibrillation, deep vein thrombosis and stroke management."
Answered by AI
Is the Apixaban film coated tablets 2.5 mg dosage officially sanctioned by the FDA?
"Our team at Power rates the safety of Apixaban film coated tablets 2.5 mg as a 3, due to existing data that demonstrates efficacy and multiple trials verifying its security profile."
Answered by AI
How many venues is this research project supervised in?
"At present, this clinical trial is offering recruitment to patients at 5 distinct sites. These are located in Calgary, Toronto and Ottawa as well as other cities. To reduce the necessity of travelling long distances for participation, it's wise to select a location close by."
Answered by AI
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