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

NCT ID: NCT06440694

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2027-12-01

Brief 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

Keywords

Proximal Lower Extremity Deep Vein Thrombosis; Randomized Trial; Colchicine; Post Thrombotic Syndrome; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Colchicine 0.5 mg po

Intervention Type: DRUG

Colchicine 0.5 mg po once daily for 180 days.

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.

Group Type: PLACEBO_COMPARATOR

Placebo 0.5 mg po

Intervention Type: DRUG

Placebo 0.5 mg po once daily for 180 days.

Interventions

Colchicine 0.5 mg po

Colchicine 0.5 mg po once daily for 180 days.

Intervention Type: DRUG

Placebo 0.5 mg po

Placebo 0.5 mg po once daily for 180 days.

Intervention Type: DRUG

Other Intervention Names

Myinfla tablet 0.5 mg po daily; Placebo 0.5 mg po daily

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Carrier, MD,MSc,FRCPC

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital

Locations

The Ottawa Hospital General Campus

Ottawa, Ontario, Canada

Site Status: RECRUITING

Centre de recherche du Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status: RECRUITING

The Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Marc Carrier, MD,MSc,FRCPC

Role: CONTACT

Phone: 6137378899

Email: mcarrier@toh.ca

Facility Contacts

Veronica Bates

Role: primary

Amélie Martin

Role: primary

Stephanie Scala

Role: primary

Other Identifiers

CONQUER-DVT Pilot

Identifier Type: -

Identifier Source: org_study_id