This trial seeks to assess the feasibility of a full-scale, double-blind, placebo-controlled, randomized trial assessing whether low-dose colchicine (0.5 mg daily) reduces the risk of post-thrombotic syndrome (PTS) in patients with proximal lower extremity deep vein thrombosis (DVT).
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).
Parallel
Colchicine 0.5 mg po
DrugColchicine 0.5 mg po once daily for 180 days.
Placebo 0.5 mg po
DrugPlacebo 0.5 mg po once daily for 180 days.
Pilot Trial Primary Outcome: Recruitment Rate
Mean number of participants recruited per site per month
Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome
VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome
Pilot Trial Secondary Outcome: Eligibility Rate
Proportion of screened patients who are eligible
Pilot Trial Secondary Outcome: Consent Rate
Proportion of eligible patients who provide consent
Pilot Trial Secondary Outcome: Retention Rate
Proportion of participants retained at follow-up
Pilot Trial Secondary Outcome: Study Completion Rate
Proportion of participants who completed all study procedures
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