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

Venous Thromboembolism Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

Purpose of the pilot trial:

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).

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

• NCT number: NCT06440694
• Study type: Interventional
• Source: Ottawa Hospital Research Institute
• Contact: Marc Carrier, MD, MSc
• Phone: 6137378899
• Email: mcarrier@toh.ca
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 3, 2024
• Completion date: December 1, 2027