NCT00689520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2002

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
Last Updated

June 3, 2008

Status Verified

May 1, 2008

Enrollment Period

3 years

First QC Date

May 28, 2008

Last Update Submit

June 2, 2008

Conditions

Venous Thromboembolism

Keywords

Venous thromboembolismlow molecular weight heparinVitamin K antagonistLongterm

Outcome Measures

Primary Outcomes (1)

  • Incidence of symptomatic recurrent venous thromboembolism

    12 months

Secondary Outcomes (1)

  • Occurrence of major bleeding

    6 month treatment interval

Study Arms (2)

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

acenocoumarol

ACTIVE COMPARATOR

tinzaparin for 1 weeks followed by acenocoumarol for 6 months

Drug: acenocoumarol

Interventions

tinzaparinDRUG

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
tinzaparin
acenocoumarolDRUG

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
acenocoumarol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vascular surgery service. Hospital Creu Roja de l'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08906, Spain

Location

Department of Vascular Surgery. Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

TinzaparinAcenocoumarolacarboxyprothrombin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Antoni Romera, MD

    Hospital Universitari de Bellvitge

    STUDY CHAIR

  • Antoni Romera, MD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

  • Oriol Lapiedra, MD

    Hospital Creu Roja de l'Hospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 3, 2008

Study Start

January 1, 2002

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

June 3, 2008

Record last verified: 2008-05

Locations

ES(2)