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

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ClinicalTrials.gov Identifier: NCT00421538
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
Swiss National Science Foundation
Ministry of Health, France
Lady Davis Institute
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Marc Righini, University Hospital, Geneva

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 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.

Condition or disease Intervention/treatment Phase
Distal (Calf) Deep-vein Thrombosis Drug: nadroparine calcium Drug: Placebo Phase 3

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 therapeutic dosage or a six-week period of placebo. All patients will be treated with elastic compression stockings and followed-up with a standardized ultrasonography protocol. Strict ultrasonographic diagnostic criteria for distal DVT have been defined. Control compression ultrasonography will be performed between days 3 and 7 and at six weeks after inclusion. The primary outcome will be a composite of the proportion of patients with extension of the thrombus to the proximal veins (detected by the programmed ultrasound examinations or by an ultrasound performed because of recurrent symptoms) or symptomatic PE in both arms of the study during the 6-weeks study period. Patients with such an outcome will be anticoagulated as currently admitted in presence of a proximal DVT. Secondary outcomes will be the individual components of the composite endpoint (distal DVT extension to proximal veins; symptomatic PE), major bleeding, serious adverse events and death reported at 6 weeks and 90 days. To answer the research question of the PTS add-on study, patients will self-assess and be assessed for PTS by a clinician using the Villalta scale, 1 year following their enrolment into the trial. In addition, patients will complete a Quality of Life (QOL) questionnaire. The QOL questionnaire will be comprised of both the VEINES-QOL and SF-36. The primary outcome is the rate of PTS, with secondary outcomes of QOL scores and PTS severity.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Contention Alone Versus Anticoagulation for Symptomatic Calf Vein Thrombosis Diagnosed by Ultrasonography
Actual Study Start Date : January 2008
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: LMWH
Therapeutic dose of Nadroparin
Drug: nadroparine calcium
Once-daily injection of 171 U/Kg/day of nadroparine calcium for 6 weeks.
Placebo Comparator: Placebo
Injectable placebo
Drug: Placebo
Once-daily injectable placebo (sterilized NaCL 0.9%) for 6 weeks



Primary Outcome Measures :
  1. Composite of rate of extension of distal DVT to proximal deep veins (includes ipsilateral extension or new contralateral proximal DVT) or symptomatic PE at 6 weeks [ Time Frame: 6 weeks ]
  2. Rate of post-thrombotic syndrome (PTS) [ Time Frame: 1 year ]
    Rate of post-thrombotic syndrome (PTS) diagnosed using the Villalta scale.


Secondary Outcome Measures :
  1. Individual components of the composite endpoint: distal DVT extension to proximal veins at 6 weeks and 90 days; PE at 6 weeks and 90 days [ Time Frame: 6 weeks and 3 months ]
  2. Major bleeding at 6 weeks and 90 days [ Time Frame: 6 weeks and 3 months ]
  3. Death at 6 weeks and 90 days [ Time Frame: 6 weeks and 3 months ]
  4. Serious adverse events at 6 weeks and 90 days [ Time Frame: 6 weeks and 3 months ]
  5. Generic and venous disease-specific Quality of Life scores [ Time Frame: 1 year ]
  6. PTS severity category [ Time Frame: 1 year ]
    Can either be mild, intermediate, severe



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421538


Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Ottawa General Hospital
Ottawa, Ontario, Canada
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada
France
Montpellier University Hospital
Montpellier, Languedoc, France, 34295
Switzerland
University Hospital of Geneva
Geneva, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
Swiss National Science Foundation
Ministry of Health, France
Lady Davis Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Marc Righini, MD Geneva University Hospital
Principal Investigator: Isabelle Quéré, MD Montpellier University Hospital
Principal Investigator: Susan Kahn, MD Jewish General Hospital
Principal Investigator: Marc Carrier, MD Ottawa Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marc Righini, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00421538     History of Changes
Obsolete Identifiers: NCT00539058
Other Study ID Numbers: 3200B0-105991
CACTUS-PTS Trial
First Posted: January 12, 2007    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Keywords provided by Marc Righini, University Hospital, Geneva:
Deep vein Thrombosis
Calf vein thrombosis
Low-molecular weight heparin
Placebo
Elastic contention
Compression Ultrasonography

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Nadroparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action