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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00689520

Enrollment

241

Registered

2008-06-03

Start date

2002-01-31

Completion date

2005-01-31

Last updated

2008-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

Venous thromboembolism, low molecular weight heparin, Vitamin K antagonist, Longterm

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.

Interventions

DRUGtinzaparin

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

DRUGacenocoumarol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of symptomatic recurrent venous thromboembolism	12 months

Secondary

Measure	Time frame
Occurrence of major bleeding	6 month treatment interval

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026