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Apixaban for Inflammatory Bowel Disease (EXPAND Trial)

Phase < 1
Recruiting
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Elective surgery
18 years old
Must not have
Emergency surgery
Women of childbearing potential unwilling/unable to participate in appropriate family planning during the treatment period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post operatively
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved

Summary

This trial will study whether a medication can help prevent blood clots in people with inflammatory bowel disease who have had surgery.

Who is the study for?
This trial is for adults with Crohn's disease or ulcerative colitis who are undergoing elective abdominal surgery at specific hospitals. They must not be pregnant, have a history of blood clots, liver disease with bleeding risk, or be on certain drugs like strong CYP3A4 inhibitors/inducers and anticoagulants.
What is being tested?
The study tests if taking Apixaban (a blood thinner) after surgery can prevent blood clots better than a placebo in IBD patients. It's randomized and placebo-controlled to compare the effectiveness and safety of extended postoperative clot prevention.
What are the potential side effects?
Apixaban may cause bleeding risks such as gastrointestinal bleeding or bruising more easily. There could also be potential allergic reactions to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am planning to have surgery that is not an emergency.
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I am 18 years old or older.
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I have been diagnosed with Crohn's disease or ulcerative colitis.
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My surgery will be at Hamilton Health Sciences or St. Joseph's Healthcare Hamilton.
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I have had surgery on my abdomen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery urgently.
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I am not willing or able to use birth control during the treatment.
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I am not currently experiencing any serious bleeding.
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I am currently undergoing treatment for cancer.
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My kidney function is very low or I am on dialysis.
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I am not taking strong inhibitors like certain antifungals or HIV medications.
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I've had bleeding issues with blood thinners after surgery before.
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I have had blood clots in the past.
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I am not taking medications like rifampicin or St. John's Wort.
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I have liver disease that increases my risk of bleeding.
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I am currently taking blood thinners.
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I need blood thinners before surgery due to a heart condition like atrial fibrillation.
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I am not taking any medications that affect blood clotting.
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I do not have conditions that increase my risk of serious bleeding.
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I have had colorectal cancer in the past.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of bleeding while undergoing treatment with oral anticoagulant or placebo.
Incidence of post operative venous thromboembolism events (DVT/PE) in in patients with Inflammatory Bowel Disease
Secondary study objectives
Incidence of surgical complications related to post operative anticoagulation

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
The treatment arm will receive a full supply of twice daily 2.5 milligram (mg) dosing of apixaban beginning on the first day of hospital discharge.
Group II: PlaceboPlacebo Group1 Intervention
The placebo group will receive a similarly appearing full supply of a twice daily placebo oral tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
FDA approved

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,615,168 Total Patients Enrolled
~15 spots leftby Dec 2025
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