Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis

June 2, 2008 updated by: Hospital Universitari de Bellvitge

Phase IV, Randomized, Open-Label Trial Comparing Long-Term Subcutaneous Low-Molecular Weight Heparin With Oral Anticoagulant Therapy in the Treatment of Deep Venous Thrombosis

The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin)administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for a similar period of time in patients with proximal venous thrombosis.

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08906
        • Vascular surgery service. Hospital Creu Roja de l'Hospitalet
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Department of Vascular Surgery. Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs.
  • either sex and over 18 years of age
  • referred to the Vascular Surgery Department of the hospital
  • onset of symptoms less than 2 weeks
  • documented by compression ultrasonography,

Exclusion Criteria:

  • received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease
  • pulmonary embolism requiring thrombolytic therapy
  • Need of surgical thrombectomy or vena cava interruption
  • receiving oral anticoagulant treatment or antiplatelet agents for other conditions
  • contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs)
  • platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia
  • severe renal failure necessitating dialysis
  • pregnancy
  • lumbar puncture within the previous 24 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tinzaparin
tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months.
Drug: tinzaparin
tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
Other Names:
  • innohep
Active Comparator: acenocoumarol
tinzaparin for 1 weeks followed by acenocoumarol for 6 months
Drug: acenocoumarol
tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months
Other Names:
  • Vitamin K antagonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic recurrent venous thromboembolism
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of major bleeding
Time Frame: 6 month treatment interval
6 month treatment interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Collaborators

LEO Pharma

Investigators

  • Study Chair: Antoni Romera, MD, Hospital Universitari de Bellvitge
  • Principal Investigator: Antoni Romera, MD, Hospital Universitari de Bellvitge
  • Principal Investigator: Oriol Lapiedra, MD, Hospital Creu Roja de l'Hospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

June 3, 2008

Last Update Submitted That Met QC Criteria

June 2, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV1/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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