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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2015 by Marc Righini, University Hospital, Geneva.
Recruitment status was: Recruiting

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

ClinicalTrials.gov Identifier:

NCT00421538

First received: January 11, 2007

Last updated: May 27, 2015

Last verified: May 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

January 11, 2007

Last Updated Date

May 27, 2015

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]
Rate of post-thrombotic syndrome (PTS) [ Time Frame: 1 year ]
Rate of post-thrombotic syndrome (PTS) diagnosed using the Villalta scale.

Original Primary Outcome Measures ^ICMJE

The main outcome will be the proportion of patients with extension of the thrombus
to the proximal veins in both arms of the study during the 6-weeks study period.

Change History

Complete list of historical versions of study NCT00421538 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
Major bleeding at 6 weeks and 90 days [ Time Frame: 6 weeks and 3 months ]
Death at 6 weeks and 90 days [ Time Frame: 6 weeks and 3 months ]
Serious adverse events at 6 weeks and 90 days [ Time Frame: 6 weeks and 3 months ]
Generic and venous disease-specific Quality of Life scores [ Time Frame: 1 year ]
PTS severity category [ Time Frame: 1 year ]
Can either be mild, intermediate, severe

Original Secondary Outcome Measures ^ICMJE

Secondary outcomes will be the rate of pulmonary embolism and of major bleeding.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Contention Alone Versus Anticoagulation for Symptomatic Calf Vein Thrombosis Diagnosed by Ultrasonography

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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Distal (Calf) Deep-vein Thrombosis

Intervention ^ICMJE

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

Study Arms

Active Comparator: LMWH
Therapeutic dose of Nadroparin

Intervention: Drug: nadroparine calcium
Placebo Comparator: Placebo
Injectable placebo

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

September 2015

Estimated Primary Completion Date

May 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada, France, Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00421538

Other Study ID Numbers ^ICMJE

3200B0-105991
CACTUS-PTS Trial

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Marc Righini, University Hospital, Geneva

Study Sponsor ^ICMJE

University Hospital, Geneva

Collaborators ^ICMJE

Swiss National Science Foundation
Ministry of Health, France
Lady Davis Institute
Canadian Institutes of Health Research (CIHR)

Investigators ^ICMJE

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

PRS Account

University Hospital, Geneva

Verification Date

May 2015

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

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