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

NCT06440694 | Recruiting Phase 3 DMC

• 1 other identifier: CONQUER-DVT Pilot
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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).

Conditions

Venous Thromboembolism

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Pilot Trial Primary Outcome: Recruitment Rate

  Mean number of participants recruited per site per month

  12 months

• Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome

  VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome

  180 days

Secondary Outcomes (17)

• Pilot Trial Secondary Outcome: Eligibility Rate

  12 months

• Pilot Trial Secondary Outcome: Consent Rate

  12 months

• Pilot Trial Secondary Outcome: Retention Rate

  12 months

• Pilot Trial Secondary Outcome: Study Completion Rate

  12 months

• Pilot Trial Secondary Outcome: Adherence Rate

  12 months

Study Arms (2)

Experimental Arm: Colchicine

EXPERIMENTAL

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.

Drug: Colchicine 0.5 mg po

Control Arm : Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo 0.5 mg po

Interventions

Colchicine 0.5 mg po DRUG

Colchicine 0.5 mg po once daily for 180 days.

Also known as: Myinfla tablet 0.5 mg po daily

Experimental Arm: Colchicine

Placebo 0.5 mg po DRUG

Placebo 0.5 mg po once daily for 180 days.

Also known as: Placebo 0.5 mg po daily

Control Arm : Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• History of cirrhosis, chronic active hepatitis, or severe liver disease.
• Recent (\<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine).
• Known active cancer.
• 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.
• Pregnancy, breast feeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex;
• The use of medication with known drug-to-drug interactions (including but not limited to erythromycin or clarithromycin).
• Unable or unwilling to provide consent.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (3)

The Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

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

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

The Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Postthrombotic Syndrome; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Thrombosis; Thrombosis; Venous Insufficiency; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Marc Carrier, MD,MSc,FRCPC

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Carrier, MD,MSc,FRCPC

CONTACT

6137378899; mcarrier@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Pilot Trial comparing two groups - Colchicine 0.5 mg po once daily for 180 days vs Placebo 0.5 mg po once daily for 180 days.

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon completion of the full-scale trial
• Access Criteria: Contact Principal Investigator

Locations

CA (3)