Clinical trial NCT06440694: Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)
Official title: Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Proximal Lower Extremity Deep Vein Thrombosis
Randomized Trial
Colchicine
Post Thrombotic Syndrome
Inflammation
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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).

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).

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.

Primary outcomes:
measure: Pilot Trial Primary Outcome: Recruitment Rate
timeFrame: 12 months
measure: Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome
timeFrame: 180 days
Secondary outcomes:
measure: Pilot Trial Secondary Outcome: Eligibility Rate
timeFrame: 12 months
measure: Pilot Trial Secondary Outcome: Consent Rate
timeFrame: 12 months
measure: Pilot Trial Secondary Outcome: Retention Rate
timeFrame: 12 months
measure: Pilot Trial Secondary Outcome: Study Completion Rate
timeFrame: 12 months
measure: Pilot Trial Secondary Outcome: Adherence Rate
timeFrame: 12 months
measure: Pilot Trial Secondary Outcome: Reasons for declining participation
timeFrame: 12 months
measure: Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome
timeFrame: 365 days
measure: Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome
timeFrame: 180 and 365 days
measure: Full-Scale Trial Secondary Outcome: Severity of Post Thrombotic Syndrome
timeFrame: 180 and 365 days
measure: Full-Scale Trial Secondary Outcome: Patient Reported V. Scale
timeFrame: 180 and 365 days
measure: Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism
timeFrame: 180 and 365 days
measure: Full-Scale Trial Secondary Outcome: Major Bleeding
timeFrame: 180 and 365 days
measure: Full-Scale Trial Secondary Outcome: Clinically Relevant Non-Major Bleeding
timeFrame: 180 and 365 days
measure: Full-Scale Trial Secondary Outcome: Overall Mortality
timeFrame: 180 and 365 days
measure: Full-Scale Trial Secondary Outcome: Venous disease Specific Quality of Life
timeFrame: 180 and 365 days
measure: Full-Scale Trial Secondary Outcome: Health-Related Quality of Life
timeFrame: 180 and 365 days
measure: Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)
timeFrame: 180 and 365 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital General Campus
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital
name: Marc Carrier, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: