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

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT06440694
Phase
PHASE3
Status
Recruiting
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Conditions

  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Colchicine 0.5 mg po — DRUG
    Colchicine 0.5 mg po once daily for 180 days.
  • Placebo 0.5 mg po — DRUG
    Placebo 0.5 mg po once daily for 180 days.

Study Details

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).

Key Dates

First listed
Jun 4, 2024
Start date
Jul 7, 2025
Status verified
Dec 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Pilot Trial Primary Outcome: Recruitment Rate [ Time Frame: 12 months ]

Central Contacts

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