Colchicine for Deep Vein Thrombosis

Overseen By Marc Carrier, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Immunosuppressives, Erythromycin, Clarithromycin

Disqualifiers: Allergy to colchicine, Active cancer, Liver disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 180

Duration: 26 weeks

150 Participants Needed

Trial Summary

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.

How is the drug colchicine unique in treating deep vein thrombosis?

Colchicine is unique in treating deep vein thrombosis because it is primarily known for its anti-inflammatory properties, which may help reduce inflammation associated with the condition, unlike traditional anticoagulants that mainly prevent clot growth. ^{1 2 3 4 5}

What is the purpose of this trial?

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).

Research Team

Marc Carrier, MD, MSc

Principal Investigator

Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital

Eligibility Criteria

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

I am 18 or older and have a confirmed deep vein thrombosis in my leg.

Exclusion Criteria

I am not taking medications like erythromycin that interact with other drugs.

History of an allergic reaction or significant sensitivity to colchicine

I am currently taking colchicine for a medical condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive colchicine 0.5 mg or placebo daily for 180 days

26 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Follow-up visits at 180 and 365 days

Treatment Details

Interventions

• Colchicine

Trial Overview The study tests if low-dose colchicine (0.5 mg daily) can prevent post-thrombotic syndrome, a complication of DVT, compared to a placebo. It's designed as a pilot for a larger trial and will randomly assign participants to either the medication or placebo group.

Participant Groups

Group I: Experimental Arm: Colchicine Experimental Treatment 1 Intervention

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.

Group II: Control Arm : Placebo Placebo Group 1 Intervention

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.

Colchicine is already approved in United States for the following indications:

Approved in United States as Colcrys for:

• Gout
• Familial Mediterranean Fever

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Catheter-directed interventions for acute iliocaval deep vein thrombosis. [2016]

2. Germany pubmed.ncbi.nlm.nih.gov

[Diagnosis and therapy of thrombophlebitis with special consideration of low molecular weight heparin]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Selective thrombolysis in acute deep vein thrombosis: evaluation of adjuvant therapy in vivo. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Enoxaparin treatment of spontaneous deep vein thrombosis in a chronically catheterized rhesus macaque (Macaca mulatta). [2021]

5. England pubmed.ncbi.nlm.nih.gov

Thrombectomy and isolated limb perfusion with urokinase in the treatment of phlegmasia cerulea dolens. [2016]