Randomized Controlled Trial of Anticoagulation vs. Placebo for a First Symptomatic Isolated Distal Deep-vein Thrombosis (IDDVT)

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks. Additionally, the study aims to determine if the 6 week course of treatment with therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency of post-thrombotic syndrome (PTS) at 1 year.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Geneva
• Collaborators: Canadian Institutes of Health Research (CIHR); Lady Davis Institute; Ministry of Health, France; Swiss National Science Foundation
• Treatments: Calcium; Nadroparin

Criteria

Inclusion Criteria:

• All outpatients with an acute, symptomatic, distal DVT will be included in the study, provided they correspond to the following diagnostic and exclusion criteria, and they have signed an informed consent form.

Exclusion Criteria:

• Age less than 18 years

• Previously objectively diagnosed DVT or PE

• Distal DVT involving the tibioperoneal trunk (i.e. calf trifurcation)

• Clinically suspected pulmonary embolism

• Active cancer, receiving cancer treatment or cancer considered cured for <6 months

• Ipsilateral or contralateral proximal DVT

• Indication for long-term anticoagulation (e.g. atrial fibrillation, mechanical heart valve...)

• Pregnancy

• Thrombocytopenia (platelet count < 100 g/l)

• Impaired renal function (serum creatinine > 180 micromol/l or clearance to creatinine less than 30 ml/min)

• Known hypersensitivity to heparin

• Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (gastric ulcer, cerebral malignant disease...)

• Treatment with daily NSAIDs (aspirin ≤160 mg/day permitted)

• Body weight >115 kg or <40 kg

• Treatment with therapeutic doses of anticoagulants for >2 days, corresponding to: 2 injections of LMWH if once daily therapeutic LMWH used; 3 injections of LMWH if twice-daily therapeutic LMWH used; 1 dose of oral vitamin K antagonist (e.g. warfarin)

• Ongoing requirement for prophylactic dose thromboprophylaxis (e.g. acute post-op patient receiving thromboprophylaxis)

• Enrolled in another clinical trial within previous 30 days

• Inability or refusal to provide informed consent