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Apixaban 2.5 milligram for Inflammatory Bowel Disease (EXPAND Trial)

Q: Is this clinical experiment pioneering in its field?

<a href="https://www.withpower.com/clinical-trials/apixaban">Apixaban</a> 2.5 milligram is currently being trialled in 34 nations, across 379 cities. This drug first entered clinical trials in 2015 when Bristol-Myers Squibb conducted a Phase 4 assessment with 4012 patients as part of the study; since then, 47 active studies have been undertaken and 282 completed thus far.

Q: In what situations is Apixaban 2.5 milligram routinely recommended?

<a href="https://www.withpower.com/clinical-trials/apixaban">Apixaban</a> 2.5 milligram is primarily utilized to treat a-fib, yet also has therapeutic potential for deep vein thrombosis, pulmonary embolism, and <a href="https://www.withpower.com/clinical-trials/stroke">stroke</a>.

Q: What is the size of the patient cohort in this medical experiment?

Affirmative. The clinicaltrials.gov website reveals that this medical trial, which went live on September 1st 2021, is still actively recruiting participants. Sixty patients need to be enrolled from two distinct sites.

Q: Are there still openings in this research experiment for participants?

As per clinicaltrials.gov, this medical trial is still in search of volunteers. The initial post was made on September 1st 2021 and the last update occured on August 26th 2022.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post operatively

Awards & highlights

EXPAND Trial 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.Check my eligibility

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.See study design

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.

EXPAND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am planning to have surgery that is not an emergency.

Select...

I am 18 years old or older.

Select...

I have been diagnosed with Crohn's disease or ulcerative colitis.

Select...

My surgery will be at Hamilton Health Sciences or St. Joseph's Healthcare Hamilton.

Select...

I have had surgery on my abdomen.

EXPAND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post operatively

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Incidence of surgical complications related to post operative anticoagulation

EXPAND 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

880 Previous Clinical Trials

2,597,768 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical experiment pioneering in its field?

"Apixaban 2.5 milligram is currently being trialled in 34 nations, across 379 cities. This drug first entered clinical trials in 2015 when Bristol-Myers Squibb conducted a Phase 4 assessment with 4012 patients as part of the study; since then, 47 active studies have been undertaken and 282 completed thus far."

Answered by AI

In what situations is Apixaban 2.5 milligram routinely recommended?

"Apixaban 2.5 milligram is primarily utilized to treat a-fib, yet also has therapeutic potential for deep vein thrombosis, pulmonary embolism, and stroke."

Answered by AI

What is the size of the patient cohort in this medical experiment?

"Affirmative. The clinicaltrials.gov website reveals that this medical trial, which went live on September 1st 2021, is still actively recruiting participants. Sixty patients need to be enrolled from two distinct sites."

Answered by AI

Are there still openings in this research experiment for participants?

"As per clinicaltrials.gov, this medical trial is still in search of volunteers. The initial post was made on September 1st 2021 and the last update occured on August 26th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease

2021. "Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03935451.

All > Inflammatory Bowel Disease > Apixaban