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

Официальное название

Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis: A Randomized Controlled Pilot Trial

Обзор

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).

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• Pilot Trial Primary Outcome: Recruitment Rate [Срок оценки: 12 months]
• Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome [Срок оценки: 180 days]

Вторичные конечные точки (12)

• Pilot Trial Secondary Outcome: Eligibility Rate [Срок оценки: 12 months]
• Pilot Trial Secondary Outcome: Consent Rate [Срок оценки: 12 months]
• Pilot Trial Secondary Outcome: Retention Rate [Срок оценки: 12 months]
• Pilot Trial Secondary Outcome: Study Completion Rate [Срок оценки: 12 months]
• Pilot Trial Secondary Outcome: Adherence Rate [Срок оценки: 12 months]
• Pilot Trial Secondary Outcome: Reasons for declining participation [Срок оценки: 12 months]
• Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome [Срок оценки: 365 days]
• Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome [Срок оценки: 180 and 365 days]
• Full-Scale Trial Secondary Outcome: Severity of Post Thrombotic Syndrome [Срок оценки: 180 and 365 days]
• Full-Scale Trial Secondary Outcome: Patient Reported VILLALTA Scale [Срок оценки: 180 and 365 days]
• Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism [Срок оценки: 180 and 365 days]
• Full-Scale Trial Secondary Outcome: Major Bleeding [Срок оценки: 180 and 365 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 4 центра

• The Ottawa Hospital General Campus — Ottawa
• Windsor Regional Hospital — Windsor
• Centre de recherche du Centre hospitalier de l'Université de Montréal — Montreal
• The Sir Mortimer B. Davis Jewish General Hospital — Montreal

Идентификаторы

NCT: NCT06440694 · CONQUER-DVT Pilot

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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