Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · May 28, 2024

Keywords

ClinConnect Summary

The Conquer-DVT Pilot Trial is a research study looking at whether a low dose of a medication called colchicine can help prevent a condition known as post-thrombotic syndrome (PTS) in patients who have recently experienced a deep vein thrombosis (DVT) in their legs. DVT is a serious condition where a blood clot forms in a deep vein, often in the legs. This pilot trial aims to see if running a larger study to test colchicine is possible, focusing on adults aged 18 and older who have had their first episode of DVT.

To be eligible for this trial, participants must be able to provide consent and should have a confirmed diagnosis of DVT in a major vein in their leg. However, individuals with certain health issues, such as allergies to colchicine, active infections, severe liver disease, or those who are pregnant, will not be able to participate. If you join the study, you will take either colchicine or a placebo (a look-alike pill with no active medication) daily for a period of time, and you will be monitored to see if this treatment helps prevent PTS. This trial is not yet recruiting participants, but it aims to provide important insights into improving care for patients with DVT in the future.

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Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 1. History of an allergic reaction or significant sensitivity to colchicine.
• • 2. Requirement of colchicine for other indications.
• • 3. 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.
• • 4. Known or suspected, recent (\<30 days) or active infections (acute or chronic).
• • 5. History of cirrhosis, chronic active hepatitis, or severe liver disease.
• • 6. Recent (\<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine).
• • 7. Known active cancer.
• • 8. 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 creatinine clearance by Cockcroft-Gault formula \<30 mL/min.
• • 9. Pregnancy, breast feeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex;
• • 10. The use of medication with known drug-to-drug interactions (including but not limited to erythromycin or clarithromycin).
• • 11. Unable or unwilling to provide consent.