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

Sponsors and Collaborators:	Hospital Universitari de Bellvitge LEO Pharma
Information provided by:	Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:	NCT00689520

Purpose

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.

Condition	Intervention	Phase
Venous Thromboembolism	Drug: tinzaparin Drug: acenocoumarol	Phase IV

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis

Drug Information available for: Heparin Vitamin K Acenocoumarol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:

Incidence of symptomatic recurrent venous thromboembolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of major bleeding [ Time Frame: 6 month treatment interval ] [ Designated as safety issue: Yes ]

Enrollment:	241
Study Start Date:	January 2002
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
tinzaparin: Experimental 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
acenocoumarol: Active Comparator 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689520

Locations

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

Sponsors and Collaborators

Hospital Universitari de Bellvitge

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

More Information

Responsible Party:	Department of Vascular Surgery. Hospital Universitari de Bellvitge ( Romera, Antonio MD )
Study ID Numbers:	CV1/01, CV1/01
Study First Received:	May 28, 2008
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00689520
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:

Venous thromboembolism
low molecular weight heparin
Vitamin K antagonist
Longterm

Study placed in the following topic categories:

Heparin, Low-Molecular-Weight
Vascular Diseases
Venous Thromboembolism
Thrombosis
Thromboembolism
Calcium heparin
Body Weight

Embolism and Thrombosis
Embolism
Acenocoumarol
Vitamin K
Tinzaparin
Venous Thrombosis
Heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009