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

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with a first, sudden blood clot in a deep vein of the leg, at or above the knee. It tests whether low-dose colchicine lowers the risk of long-term leg problems after the clot.

Életkor

18 years or older

Nem

All

A betegség stádiuma

A first, acute deep vein thrombosis (DVT) of the leg that causes symptoms. It must be in the popliteal vein (behind the knee) or higher, and confirmed by a test.

Korábbi kezelés

People cannot join if they used systemic immunosuppressive drugs (such as steroids, tumor necrosis factor-alpha blockers, cyclosporine) in the last 30 days or long term.

A részvétel fő kizáró okai

• Allergy or strong sensitivity to colchicine, or already needing colchicine for another reason
• Ongoing diarrhea, inflammatory bowel disease, irritable bowel syndrome or blood disorders
• Recent (<30 days) or active infection, known active cancer, or serious liver disease such as cirrhosis
• Liver enzymes >3 times or bilirubin >2 times the upper limit of normal, or creatinine clearance <30 mL/min
• Pregnancy, breastfeeding, planning pregnancy, or not willing to use birth control; use of interacting drugs such as erythromycin or clarithromycin

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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).

A vizsgálat 2 csoportja

• Experimental Arm: ColchicineA vizsgált kezelés

  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.

  Kezelés: Colchicine 0.5 mg po

• Control Arm : PlaceboPlacebo, összehasonlításként

  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.

  Kezelés: Placebo 0.5 mg po