Randomized Controlled Trial of Anticoagulation vs. Placebo for a First Symptomatic Isolated Distal Deep-vein Thrombosis (IDDVT) (CACTUS-PTS)
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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 |
- 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.
- 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 |
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| 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, 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 | |
| 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:
|
Scheuermann Disease Spinal Osteochondrosis Thrombosis Venous Thrombosis Osteochondrosis Bone Diseases Musculoskeletal Diseases Kyphosis 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 May 23, 2013