Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis: A Randomized Controlled Pilot Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Canada
Centre de recherche du Centre hospitalier de l'Université de Montréal
RECRUITING
Montreal
The Sir Mortimer B. Davis Jewish General Hospital
NOT_YET_RECRUITING
Montreal
The Ottawa Hospital General Campus
RECRUITING
Ottawa
Contact Information
Primary
Marc Carrier, MD,MSc,FRCPC
mcarrier@toh.ca
6137378899
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 150
Treatments
Experimental: Experimental Arm: Colchicine
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.
Placebo_comparator: Control Arm : Placebo
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.
Related Therapeutic Areas
Sponsors
Leads: Ottawa Hospital Research Institute