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

January 11, 2007
August 24, 2012
January 2008
May 2015   (final data collection date for primary outcome measure)
  • 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.
  • to the proximal veins in both arms of the study during the 6-weeks study period.
  • The main outcome will be the proportion of patients with extension of the thrombus
Complete list of historical versions of study NCT00421538 on ClinicalTrials.gov Archive Site
  • 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
Secondary outcomes will be the rate of pulmonary embolism and of major bleeding.
Not Provided
Not Provided
 
Randomized Controlled Trial of Anticoagulation vs. Placebo for a First Symptomatic Isolated Distal Deep-vein Thrombosis (IDDVT)
Contention Alone Versus Anticoagulation for Symptomatic Calf Vein Thrombosis Diagnosed by Ultrasonography

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Distal (Calf) Deep-vein Thrombosis
  • Drug: nadroparine calcium
    Once-daily injection of 171 U/Kg/day of nadroparine calcium for 6 weeks.
  • Drug: Placebo
    Once-daily injectable placebo (sterilized NaCL 0.9%) for 6 weeks
  • Active Comparator: LMWH
    Therapeutic dose of Nadroparin
    Intervention: Drug: nadroparine calcium
  • Placebo Comparator: Placebo
    Injectable placebo
    Intervention: Drug: Placebo
Guanella R, Righini M. Serial limited versus single complete compression ultrasonography for the diagnosis of lower extremity deep vein thrombosis. Semin Respir Crit Care Med. 2012 Apr;33(2):144-50. doi: 10.1055/s-0032-1311793. Epub 2012 May 30. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
September 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Canada,   France,   Switzerland
 
NCT00421538
3200B0-105991, CACTUS-PTS Trial
Yes
Marc Righini, University Hospital, Geneva
University Hospital, Geneva
  • Swiss National Science Foundation
  • Ministry of Health, France
  • Lady Davis Institute for Medical Research, Montreal
  • Canadian Institutes of Health Research (CIHR)
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
University Hospital, Geneva
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP