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

NCT ID: NCT00689520

Last Updated: 2008-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Venous Thromboembolism

Keywords

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Venous thromboembolism low molecular weight heparin Vitamin K antagonist Longterm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tinzaparin

tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months.

Group Type EXPERIMENTAL

tinzaparin

Intervention Type DRUG

tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months

acenocoumarol

tinzaparin for 1 weeks followed by acenocoumarol for 6 months

Group Type ACTIVE_COMPARATOR

acenocoumarol

Intervention Type DRUG

tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months

Interventions

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tinzaparin

tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months

Intervention Type DRUG

acenocoumarol

tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months

Intervention Type DRUG

Other Intervention Names

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innohep Vitamin K antagonists

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

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Department of Vascular Surgery. Hospital Universitari de Bellvitge

Principal Investigators

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Antoni Romera, MD

Role: STUDY_CHAIR

Hospital Universitari de Bellvitge

Antoni Romera, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Oriol Lapiedra, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Creu Roja de l'Hospitalet

Locations

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Vascular surgery service. Hospital Creu Roja de l'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Department of Vascular Surgery. Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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CV1/01

Identifier Type: -

Identifier Source: secondary_id

CV1/01

Identifier Type: -

Identifier Source: org_study_id