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

NCT00421538 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2018-05-04

No results posted yet for this study

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.

Conditions

  • Distal (Calf) Deep-vein Thrombosis

Interventions

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

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Lady Davis Institute

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Marc Righini, MD · University Hospital, Geneva

  • Isabelle Quéré, MD · Montpellier University Hospital

  • Susan Kahn, MD · Jewish General Hospital

  • Marc Carrier, MD · Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2015-05-31
Completion
2015-08-31

Countries

  • Canada
  • France
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00421538 on ClinicalTrials.gov