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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University Hospital, Geneva
Sponsor:
Collaborators:
Swiss National Science Foundation
Ministry of Health, France
Lady Davis Institute for Medical Research, Montreal
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Marc Righini, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00421538
First received: January 11, 2007
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Distal (Calf) Deep-vein Thrombosis
Drug: nadroparine calcium
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Contention Alone Versus Anticoagulation for Symptomatic Calf Vein Thrombosis Diagnosed by Ultrasonography

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Rate of post-thrombotic syndrome (PTS) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Rate of post-thrombotic syndrome (PTS) diagnosed using the Villalta scale.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Major bleeding at 6 weeks and 90 days [ Time Frame: 6 weeks and 3 months ] [ Designated as safety issue: Yes ]
  • Death at 6 weeks and 90 days [ Time Frame: 6 weeks and 3 months ] [ Designated as safety issue: Yes ]
  • Serious adverse events at 6 weeks and 90 days [ Time Frame: 6 weeks and 3 months ] [ Designated as safety issue: Yes ]
  • Generic and venous disease-specific Quality of Life scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • PTS severity category [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Can either be mild, intermediate, severe


Estimated Enrollment: 600
Study Start Date: January 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421538

Contacts
Contact: Marc Righini, MD 00 41 22 372 92 94 marc.righini@hcuge.ch
Contact: Susan Kahn, MD 514-340-8222 ext 4667 susan.kahn@mcgill.ca

Locations
Canada, Ontario
Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Sam Schulman, MD    905-527-0271 ext 44479    schulms@mcmaster.ca   
Principal Investigator: Sam Schulman, MD         
Ottawa General Hospital Recruiting
Ottawa, Ontario, Canada
Contact: Marc Carrier, MD       mcarrier@ottawahospital.on.ca   
Principal Investigator: Marc Carrier, MD         
Canada, Quebec
Hopital Maisonneuve-Rosemont Not yet recruiting
Montreal, Quebec, Canada
Contact: Jeannine Kassis, MD       jkassis@ssss.gouv.qc.ca   
Principal Investigator: Jeannine Kassis, MD         
Jewish General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Susan Kahn, MD    514-340-8222 ext 4667    susan.kahn@mcgill.ca   
Principal Investigator: Susan Kahn, MD         
Canada, Saskatchewan
Royal University Hospital Not yet recruiting
Saskatoon, Saskatchewan, Canada
Contact: Otto Moodley, MD       omoodley@saskcancer.ca   
Principal Investigator: Otto Moodley, MD         
France
Montpellier University Hospital Recruiting
Montpellier, Languedoc, France, 34295
Contact: Isabelle Quéré, MD    0033 4 67 33 70 24    i-quere@chu-montpellier.fr   
Principal Investigator: Isabelle Quéré, MD         
Switzerland
University Hospital of Geneva Recruiting
Geneva, Switzerland
Contact: Marc Righini, MD    0041 22 372 92 94    marc.righini@hcuge.ch   
Principal Investigator: Marc Righini, MD         
Sponsors and Collaborators
University Hospital, Geneva
Swiss National Science Foundation
Ministry of Health, France
Lady Davis Institute for Medical Research, Montreal
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
  More Information

No publications provided by University Hospital, Geneva

Additional 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
Study First Received: January 11, 2007
Last Updated: August 24, 2012
Health Authority: Canada: Health Canada
France: AFSSAPS
Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Kyphosis
Scheuermann Disease
Spinal Osteochondrosis
Thrombosis
Venous Thrombosis
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Spinal Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Nadroparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014