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CompletedNCT00689520Updated Jun 3, 2008

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

A Phase 4 interventional study of tinzaparin and acenocoumarol in Venous Thromboembolism, sponsored by Hospital Universitari de Bellvitge. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-03.

Sponsored by Hospital Universitari de Bellvitge · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
241
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Venous Thromboembolism

Keywords

  • Venous thromboembolism
  • low molecular weight heparin
  • Vitamin K antagonist
  • Longterm
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 241 is above the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Hospital Universitari de Bellvitge is the lead sponsor of 118 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
241 participants (actual)

Study arms

  • Experimental
    tinzaparin

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

    Drug: tinzaparin

  • Active comparator
    acenocoumarol

    tinzaparin for 1 weeks followed by acenocoumarol for 6 months

    Drug: acenocoumarol

Interventions

  • Drugtinzaparin

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

    Also known as: innohep

  • Drugacenocoumarol

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

    Also known as: Vitamin K antagonists

06

What researchers measure

Primary outcomes

  1. Incidence of symptomatic recurrent venous thromboembolism

    Time frame: 12 months

Secondary outcomes

  1. Occurrence of major bleeding

    Time frame: 6 month treatment interval

07

Study locations

2 sites
  • Vascular surgery service. Hospital Creu Roja de l'Hospitalet
    L'Hospitalet de Llobregat, Barcelona 08906, Spain
  • Department of Vascular Surgery. Hospital Universitari de Bellvitge
    L'Hospitalet de Llobregat, Barcelona 08907, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00689520
Lead sponsor
Hospital Universitari de Bellvitge
Collaborators
LEO Pharma
First posted
Jun 3, 2008
Start date
Jan 2002
Primary completion
Jan 2005
Completion
Jan 2005
Last update
Jun 3, 2008

Study contacts

Antoni Romera, MD
study chair · Hospital Universitari de Bellvitge
Antoni Romera, MD
principal investigator · Hospital Universitari de Bellvitge
Oriol Lapiedra, MD
principal investigator · Hospital Creu Roja de l'Hospitalet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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