NCT06440694

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

Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis: A Randomized Controlled Pilot Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Eligible and consenting patients will be randomized via a central web-based randomization system (1:1 ratio) to receive one tablet of colchicine 0.5 mg or identical matching placebo daily starting within 7 days of initiation of anticoagulation for acute, symptomatic, proximal lower extremity Deep Vein Thrombosis (DVT) for a treatment course of 180 days (+/- 7 days). Study drug will start within 24 hours of randomization. The type, dose, and duration of anticoagulant therapy : unfractionated heparin, Low Molecular Weight Heparin (LMWH), fondaparinux, Direct Oral Anticoagulation (DOAC) or Vitamin K Agonist (VKA) will be left to the discretion of the treating physician or local investigator. The study drug will be continued until the end of the treatment period (180 days +/- 7 days). All patients will be observed until the end of study follow-up (365 days +/- 7 days).

Conditions

• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Colchicine 0.5 mg po	Colchicine 0.5 mg po once daily for 180 days.
DRUG	Placebo 0.5 mg po	Placebo 0.5 mg po once daily for 180 days.

Timeline

• Start date: 2025-07-07
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-06-04
• Last updated: 2025-12-30

Locations

3 sites across 1 country: Canada