Status:
COMPLETED
Randomized Controlled Trial of Anticoagulation vs. Placebo for a First Symptomatic Isolated Distal Deep-vein Thrombosis (IDDVT)
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
Swiss National Science Foundation
Ministry of Health, France
Conditions:
Distal (Calf) Deep-vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The CACTUS-PTS study will compare anticoagulant treatment for 6 weeks versus placebo in acute, symptomatic distal DVT. Patients will be randomized to receive either a six-week period of LMWH at therap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00421538
Start Date
January 1 2008
End Date
August 1 2015
Last Update
May 4 2018
Active Locations (7)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
2
Ottawa General Hospital
Ottawa, Ontario, Canada
3
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
4
Jewish General Hospital
Montreal, Quebec, Canada