Colchicine for Deep Vein Thrombosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a low dose of colchicine can prevent post-thrombotic syndrome (pain and swelling after a blood clot) in individuals who have experienced a deep vein thrombosis (DVT) in their leg. Participants will take either colchicine or a placebo (a pill with no active medicine) daily for 180 days. Individuals who have recently experienced their first, painful, and confirmed DVT in the large veins of their leg may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using medications that interact with colchicine, like erythromycin or clarithromycin, you may not be eligible to participate.
Is there any evidence suggesting that colchicine is likely to be safe for humans?
Research has shown that colchicine has been studied for various uses, particularly for heart conditions. A large study tested low-dose colchicine in over 4,700 people with heart disease. Most participants tolerated it well, though some experienced side effects like stomach upset and diarrhea. Serious side effects were rare.
Colchicine is generally considered safe and is approved for conditions like gout and pericarditis (swelling around the heart). However, as with any medication, both the benefits and risks must be considered. Participants in clinical trials help researchers better understand these risks, especially for new uses of colchicine.12345Why do researchers think this study treatment might be promising for DVT?
Unlike the standard treatments for deep vein thrombosis, which often include anticoagulants like warfarin and direct oral anticoagulants such as rivaroxaban, colchicine offers a unique approach. Colchicine is primarily known for its anti-inflammatory properties, commonly used in conditions like gout, but it may also reduce inflammation in blood vessels, potentially preventing clot formation. Researchers are excited because this anti-inflammatory action could provide an alternative or complementary option with a different mechanism of action, potentially offering benefits in terms of safety and efficacy for patients who cannot tolerate standard anticoagulants.
What evidence suggests that colchicine might be an effective treatment for deep vein thrombosis?
This trial will compare colchicine with a placebo for treating deep vein thrombosis (DVT), a type of blood clot often found in the legs. Research has shown that colchicine might help treat DVT. One study found colchicine more effective than edoxaban, a common blood thinner, for treating DVT in the legs. Colchicine reduces inflammation, which has been shown to lower heart-related problems in other conditions. This suggests it might also reduce inflammation linked to DVT and prevent issues like post-thrombotic syndrome. While more research is needed, these findings offer hope for colchicine's potential benefits for DVT patients.23567
Who Is on the Research Team?
Marc Carrier, MD, MSc
Principal Investigator
Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital
Are You a Good Fit for This Trial?
This trial is for individuals with a recent proximal lower extremity deep vein thrombosis (DVT), which is a type of blood clot in the legs. The full eligibility criteria are not provided, but typically participants must meet certain health conditions and cannot have factors that would exclude them from safely participating.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive colchicine 0.5 mg or placebo daily for 180 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Colchicine
Colchicine is already approved in United States for the following indications:
- Gout
- Familial Mediterranean Fever
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor