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.