Deep vein thrombosis (DVT) is a condition in which a blood clot forms in the deep veins of the leg and can lead to long-term problems such as leg pain, swelling, and reduced quality of life. Standard treatment with blood-thinning medication lowers the risk of complications, but some patients still develop long-term damage to the veins. Inflammation is thought to play an important role in these complications.
This study will evaluate whether adding colchicine, an anti-inflammatory medication already used for other conditions, to standard anticoagulant therapy can improve outcomes in patients with acute DVT. Participants will be randomly assigned to receive either colchicine or a placebo, in addition to usual blood-thinning treatment, and will be followed for one year.
The main goal of the study is to determine whether colchicine reduces the risk of developing long-term vein problems after DVT. The study will also assess the risk of new blood clots, vein recovery, quality of life, and the safety of colchicine treatment.
Age ≥18 years at the time of screening.
Objectively confirmed first, symptomatic acute proximal lower-limb deep vein thrombosis (DVT), involving the popliteal vein or more proximal veins, diagnosed within the previous 48 hours.
Low-molecular-weight heparin (LMWH) bridging to vitamin K antagonists (VKA) or direct oral anticoagulants (DOACs),
DOAC monotherapy according to local guidelines,
History of prior DVT in the same limb.
Known contraindications to anticoagulation or anticipated inability to comply with study procedures.
Current use of colchicine or clinical indication requiring colchicine therapy.
Known hypersensitivity or allergy to colchicine.
Parallel
Colchicine 0.5 MG Oral Tablet
DrugLow-dose colchicine added to standard anticoagulant therapy for acute proximal deep vein thrombosis. Colchicine is administered 0.5 mg twice daily for the first month, then 0.5 mg once daily for the next five months. Participants are monitored for post-thrombotic syndrome, recurrent venous thromboembolism, vein recanalization, quality of life, and safety over 12 months.
Placebo
DrugMatching placebo administered alongside standard anticoagulant therapy on the same schedule as colchicine. Participants are monitored for the same outcomes and safety measures.
Post-thrombotic syndrome (PTS)
To determine whether addition of low-dose colchicine to standard anticoagulation reduces the incidence of PTS at 12 months in patients with acute proximal lower-limb DVT. PTS is defined as: chronic clinical condition that occurs after DVT, presenting with symptoms such as leg pain, heaviness, cramps, pruritus, and paresthesia, and signs such as edema, skin hyperpigmentation, venous ectasia, lipodermatosclerosis, or venous ulcer, in the previously thrombosed limb, between 3 to 12 months after the acute event, and not explained by other causes \[31\]. A Villalta score \> 5 is considered diagnostic for PTS.
Recurrent venous thromboembolism.
To evaluate the effect of low-dose colchicine added to standard anticoagulation on the incidence of recurrent venous thromboembolism (VTE), defined as objectively confirmed recurrent DVT and/or pulmonary embolism (PE), within 12 months of the index event.
Longitudinal evaluation of PTS severity
Subgroup analysis evaluating differences in efficacy of low-dose colchicine added to standard anticoagulation in mild (5-9) to moderate (10-14) to severe PTS (\> 15).
Venous healing and function on imaging
To assess the effect of colchicine on venous recanalization and valvular competence at 3 months using duplex ultrasound, including: 1. vein compressibility, 2. residual vein obstruction, 3. presence of venous reflux.
Change From Baseline in Health-Related Quality of Life (HRQOL) as Measured by the VEINES-QOL/Sym Questionnaire
Change from baseline in health-related quality of life as measured by the Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire. The VEINES-QOL score ranges from 0 to 100, with higher scores indicating better quality of life. The VEINES-Sym score ranges from 0 to 100, with higher scores indicating fewer symptoms.
Adverse event and treatment discontinuation
To determine the 12-months safety profile of colchicine in this population (major and clinically relevant non-major bleeding, defined by ISTH definitions, gastrointestinal adverse events, neutropenia).
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