60 Participants Needed

Apixaban for Inflammatory Bowel Disease

(EXPAND Trial)

Recruiting at 1 trial location
CE
TM
Overseen ByTyler McKechnie, MD

Trial Summary

What is the purpose of this trial?

Inflammatory bowel disease (IBD) is a relatively common disease that effects all age groups and carries significant morbidity and mortality. The initial treatment typically involves both short and long term medication, however when this is not enough to adequately control the disease, surgery is often required. The high morbidity and mortality rates are in part due to the increased rates of venous thromboembolism (VTE) such as deep vein thrombosis (DVT) or pulmonary embolism (PE) which have been shown to develop more frequently in IBD patients compared to the general population. Undergoing abdominal surgery has also been shown to independently increase rates of DVT and PE and since the majority of patients with IBD will undergo surgery at least once in their lifetime, the relative increased risk of developing a VTE is very high. The majority of DVT and PE events in the postoperative IBD population will occur after discharge from hospital and therefore carries significant morbidity and mortality risk in a unmonitored setting. Several studies have demonstrated the benefits and safety of twice daily dosing of oral extended VTE prophylaxis agents in orthopedic and cancer postoperative patients following discharge from hospital. There have been no randomized studies which have evaluated the use of extended postoperative VTE prophylaxis in IBD patients. The purpose of this randomized placebo controlled pilot trial will be to evaluate the efficacy and safety of postoperative VTE prophylaxis in IBD patients following abdominal surgery. If this pilot trial demonstrates efficacy in reducing postoperative DVT and PE rates, safety and feasibility, clinicians will be armed with the knowledge to pursue a larger multicenter randomized trial with the intent of reducing overall morbidity and mortality in this high risk population.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to join this trial. Specifically, if you are on strong inhibitors or inducers of CYP 3A4 and P-gp, drugs affecting blood clotting, or any anticoagulants, you would not be eligible to participate.

How does the placebo drug differ from other treatments for inflammatory bowel disease?

The placebo drug used in the trial is a dummy pill with no active ingredients, unlike other treatments for inflammatory bowel disease that contain active substances designed to reduce inflammation or suppress the immune system.12345

Eligibility Criteria

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.

Inclusion Criteria

I am planning to have surgery that is not an emergency.
I am 18 years old or older.
I have been diagnosed with Crohn's disease or ulcerative colitis.
See 3 more

Exclusion Criteria

I need surgery urgently.
I am not willing or able to use birth control during the treatment.
I am not currently experiencing any serious bleeding.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive twice daily dosing of apixaban or placebo starting on the first day of hospital discharge

3 months
Regular follow-up visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of VTE and bleeding events

3 months

Treatment Details

Interventions

  • Apixaban
  • Placebo Oral Tablet
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Findings from Research

Apixaban is an effective oral anticoagulant that inhibits factor Xa, approved for various thromboembolic disorders, including stroke prevention in atrial fibrillation and treatment of deep vein thrombosis, with a bioavailability of about 50%.
The drug is rapidly absorbed and has a predictable pharmacokinetic profile across diverse patient populations, allowing for fixed dosing without the need for routine monitoring, and it shows minimal interactions with other medications.
Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review.Byon, W., Garonzik, S., Boyd, RA., et al.[2021]
Apixaban is a highly selective factor Xa inhibitor that demonstrated potent anticoagulant properties in vitro, with a very low inhibition constant (K(i)) of 0.08 nm for human FXa, indicating its effectiveness in preventing blood clots.
In rabbit models, apixaban effectively prevented thrombosis at doses that did not significantly affect bleeding time, suggesting it can reduce clot formation while maintaining normal hemostasis.
Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies.Wong, PC., Crain, EJ., Xin, B., et al.[2023]
Apixaban is a highly effective oral anticoagulant that directly inhibits activated factor X, which plays a crucial role in blood clotting, and it also helps prevent platelet aggregation.
This medication has predictable pharmacokinetics, minimal food and drug interactions, and a wide therapeutic window, making it safe and convenient for patients, as it can be taken with or without food.
Apixaban - Metabolism, Pharmacologic Properties and Drug Interactions.Kubisz, P., Stanciakova, L., Dobrotova, M., et al.[2018]

References

Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review. [2021]
Apixaban, an oral, direct and highly selective factor Xa inhibitor: in vitro, antithrombotic and antihemostatic studies. [2023]
Apixaban - Metabolism, Pharmacologic Properties and Drug Interactions. [2018]
Therapeutic potential of apixaban in the prevention of venous thromboembolism in patients undergoing total knee replacement surgery. [2012]
Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects. [2022]