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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440694
• Other study ID #: CONQUER-DVT Pilot
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 3, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: May 2024
• Source: Ottawa Hospital Research Institute
• Contact: Marc Carrier, MD, MSc
• Phone: 6137378899
• Email: mcarrier[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Colchicine 0.5 mg po
Colchicine 0.5 mg po once daily for 180 days.
• Placebo 0.5 mg po
Placebo 0.5 mg po once daily for 180 days.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital General Campus	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pilot Trial Primary Outcome: Recruitment Rate	Mean number of participants recruited per site per month	12 months
Primary	Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome	V. score =5	180 days
Secondary	Pilot Trial Secondary Outcome: Eligibility Rate	Proportion of screened patients who are eligible	12 months
Secondary	Pilot Trial Secondary Outcome: Consent Rate	Proportion of eligible patients who provide consent	12 months
Secondary	Pilot Trial Secondary Outcome: Retention Rate	Proportion of participants retained at follow-up	12 months
Secondary	Pilot Trial Secondary Outcome: Study Completion Rate	Proportion of participants who completed all study procedures	12 months
Secondary	Pilot Trial Secondary Outcome: Adherence Rate	Adherence to study drug measured by pill count at the end of follow-up	12 months
Secondary	Pilot Trial Secondary Outcome: Reasons for declining participation	Pilot Trial Secondary Outcome: Reasons for declining participation	12 months
Secondary	Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome	V. score =5	365 days
Secondary	Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome	V. score = 15 or presence of ulcer	180 and 365 days
Secondary	Full-Scale Trial Secondary Outcome: Severity of Post Thrombotic Syndrome	Continuous V. score	180 and 365 days
Secondary	Full-Scale Trial Secondary Outcome: Patient Reported V. Scale	Full-Scale Trial Secondary Outcome: Patient Reported V. Scale	180 and 365 days
Secondary	Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism	Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism	180 and 365 days
Secondary	Full-Scale Trial Secondary Outcome: Major Bleeding	As per International Society on Thrombosis and Haemostasis (ISTH) definition	180 and 365 days
Secondary	Full-Scale Trial Secondary Outcome: Clinically Relevant Non-Major Bleeding	As per ISTH definition	180 and 365 days
Secondary	Full-Scale Trial Secondary Outcome: Overall Mortality	Full-Scale Trial Secondary Outcome: Overall Mortality	180 and 365 days
Secondary	Full-Scale Trial Secondary Outcome: Venous disease Specific Quality of Life	Scoring using VEINES-QOL/Sym	180 and 365 days
Secondary	Full-Scale Trial Secondary Outcome: Health-Related Quality of Life	Scoring using EuroQoL-EQ-5D-5L	180 and 365 days
Secondary	Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)	Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)	180 and 365 days