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

This study has been completed.

Sponsor:

Collaborator:

LEO Pharma

Information provided by:

Hospital Universitari de Bellvitge

ClinicalTrials.gov Identifier:

NCT00689520

First received: May 28, 2008

Last updated: June 2, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 28, 2008

Last Updated Date

June 2, 2008

Start Date ^ICMJE

January 2002

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00689520 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Venous Thromboembolism

Intervention ^ICMJE

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:
- tinzaparin
- innohep
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:
- Acenocoumarol
- Vitamin K antagonists

Study Arm (s)

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

Intervention: Drug: tinzaparin
Active Comparator: acenocoumarol
tinzaparin for 1 weeks followed by acenocoumarol for 6 months

Intervention: Drug: acenocoumarol

Publications *

Not Provided

* 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

Completed

Enrollment ^ICMJE

241

Completion Date

January 2005

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00689520

Other Study ID Numbers ^ICMJE

CV1/01, CV1/01

Has Data Monitoring Committee

Responsible Party

Romera, Antonio MD, Department of Vascular Surgery. Hospital Universitari de Bellvitge

Study Sponsor ^ICMJE

Hospital Universitari de Bellvitge

Collaborators ^ICMJE

LEO Pharma

Investigators ^ICMJE

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

Information Provided By

Hospital Universitari de Bellvitge

Verification Date

May 2008

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

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