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

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689520
• Other study ID #: CV1/01
• Secondary ID: CV1/01
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2008
• Last updated: June 2, 2008
• Start date: January 2002
• Est. completion date: January 2005

Study information

• Verified date: May 2008
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• tinzaparin
tinzaparin (Innohep®) subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
• acenocoumarol
tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months

Locations

Country	Name	City	State
Spain	Department of Vascular Surgery. Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Vascular surgery service. Hospital Creu Roja de l'Hospitalet	L'Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	LEO Pharma

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of symptomatic recurrent venous thromboembolism		12 months	No
Secondary	Occurrence of major bleeding		6 month treatment interval	Yes