Venous Thromboembolism study: Colchicine
Official title Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)
ClinicalTrials.gov ID: NCT06440694
What this study is testing
What is Colchicine 0.5 mg po?
Colchicine 0.5 mg po is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for venous thromboembolism.
Also referred to as Myinfla tablet 0.5 mg po daily.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether taking colchicine daily can reduce the chance of developing post‑thrombotic syndrome after a proximal lower‑leg DVT.
- Who it's for
- Adults who have recently had a proximal deep vein thrombosis in the lower leg.
- What's involved
- You will take a 0.5 mg colchicine pill (or a placebo) each day and attend scheduled visits for check‑ups and tests.
- Time commitment
- You will be followed for several months with periodic clinic visits to monitor your health.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Consenting patients 18 years of age or older with a first, acute, symptomatic proximal (popliteal vein or more proximal) objectively confirmed DVT of...
You likely can't join if
- History of an allergic reaction or significant sensitivity to colchicine.
- Requirement of colchicine for other indications.
- Active or chronic diarrhea, or documented inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), collagenous colitis or irritable...
- Known or suspected, recent (\<30 days) or active infections (acute or chronic).
- History of cirrhosis, chronic active hepatitis, or severe liver disease.
- Recent (\<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis...
See the full eligibility criteria
- 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.
- History of an allergic reaction or significant sensitivity to colchicine.
- Requirement of colchicine for other indications.
- Active or chronic diarrhea, or documented inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), collagenous colitis or irritable bowel syndrome or existing blood dyscrasias.
- Known or suspected, recent (\<30 days) or active infections (acute or chronic).
- History of cirrhosis, chronic active hepatitis, or severe liver disease.
- Recent (\<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine).
- Known active cancer.
- Any of the following as measured within the past 1-3 months or at screening: alanine, or aspartate aminotransferase \>3 times the upper limit of normal, total bilirubin \>2 times the upper limit of normal and a...
- Pregnancy, breast feeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex;
- The use of medication with known drug-to-drug interactions (including but not limited to erythromycin or clarithromycin).
- Unable or unwilling to provide consent.
The study team makes the final eligibility decision.
Where it is enrolling
- Ottawa, Ontario, Canada
- Windsor, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ottawa, Ontario, Canada; Windsor, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.