Apixaban for Inflammatory Bowel Disease
(EXPAND Trial)
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive twice daily dosing of apixaban or placebo starting on the first day of hospital discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment, including incidence of VTE and bleeding events
Treatment Details
Interventions
- Apixaban
- Placebo Oral Tablet
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor