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Anti-inflammatory

Colchicine for Deep Vein Thrombosis

Phase 3
Waitlist Available
Led By Marc Carrier, MD, MSc
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Consenting patients 18 years of age or older with a first, acute, symptomatic proximal (popliteal vein or more proximal) objectively confirmed DVT of the lower extremity will be eligible to participate in the study.
Be older than 18 years old
Must not have
Requirement of colchicine for other indications
Known or suspected, recent (<30 days) or active infections (acute or chronic)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

"This trial aims to see if a low dose of colchicine can help reduce the risk of post-thrombotic syndrome in patients with deep vein thrombosis in their legs."

Who is the study for?
This trial is for individuals with a recent proximal lower extremity deep vein thrombosis (DVT), which is a type of blood clot in the legs. The full eligibility criteria are not provided, but typically participants must meet certain health conditions and cannot have factors that would exclude them from safely participating.
What is being tested?
The study tests if low-dose colchicine (0.5 mg daily) can prevent post-thrombotic syndrome, a complication of DVT, compared to a placebo. It's designed as a pilot for a larger trial and will randomly assign participants to either the medication or placebo group.
What are the potential side effects?
Colchicine may cause side effects such as gastrointestinal discomfort, nausea, diarrhea, or less commonly bone marrow suppression and muscle inflammation. Placebo pills should not cause any direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and have a confirmed deep vein thrombosis in my leg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking colchicine for a medical condition.
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I do not have any recent or active infections.
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I have chronic diarrhea or a diagnosed bowel disease like Crohn's.
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I have a history of severe liver disease, cirrhosis, or chronic hepatitis.
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I have not been on long-term immune-weakening drugs recently.
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I currently have active cancer.
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I am not taking medications like erythromycin that interact with other drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Full-Scale Trial : Post Thrombotic Syndrome
Pilot Trial : Recruitment Rate
Secondary outcome measures
Full-Scale Trial : Clinically Relevant Non-Major Bleeding
Full-Scale Trial : Health-Related Quality of Life
Full-Scale Trial : Incremental Cost-Effectiveness Ratio (ICER)
+14 more

Side effects data

From 2021 Phase 4 trial • 280 Patients • NCT01709981
1%
Chest pain
1%
Ischemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Colchicine
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental Arm: ColchicineExperimental Treatment1 Intervention
Colchicine 0.5 mg po once daily for 180 days. After the Day - 180 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
Group II: Control Arm : PlaceboPlacebo Group1 Intervention
Placebo 0.5 mg po once daily for 180 days. After the Day - 180 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
565 Previous Clinical Trials
2,786,023 Total Patients Enrolled
11 Trials studying Deep Vein Thrombosis
4,089 Patients Enrolled for Deep Vein Thrombosis
Marc Carrier, MD, MScPrincipal InvestigatorOttawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital
~100 spots leftby Dec 2027
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