NCT00711308

Brief Summary

The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_4

Geographic Reach
1 country

4 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

April 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

Enrollment Period

3.8 years

First QC Date

July 3, 2008

Last Update Submit

February 12, 2009

Conditions

Acute Pulmonary Embolism

Keywords

pulmonary embolismlow molecular weight heparinvitamin K antagonistLongterm

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin

    6 months

Secondary Outcomes (2)

  • direct and indirect cost of each treatment regimen

    6 months

  • Major haemorrhagic events

    6 months

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 followed by acenocoumarol for 6 months

Drug: tinzaparinDrug: 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
acenocoumaroltinzaparin
acenocoumarolDRUG

acenocoumarol for 6 months

Also known as: vitamin K antagonist
acenocoumarol

Eligibility Criteria

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

You may qualify if:

  • Symptomatic pulmonary embolism patients confirmed by:
  • High probability ventilation/perfusion lung scan according to the PIOPED criteria
  • Spiral chest computed tomography, or
  • Pulmonary arteriography
  • Aged 18 years or above, of either sex
  • The patient must provide signed informed consent
  • Patients will be agreed for receiving ambulatory anticoagulant treatment

You may not qualify if:

  • Massive pulmonary embolism
  • Allergy to heparin, other components of Tinzaparin or acenocoumarol
  • Previous thrombocytopenia induced by heparin
  • Thrombocytopenia \< 100000/mm3
  • History/signs/symptoms of congenital bleeding disorder
  • Life expectancy less than 90 days
  • Unfractioned heparin anticoagulation for more than 36 hours prior enrollment
  • Inability to participate in the home tinzaparin program
  • Clinical overt gastrointestinal blood loss due to peptic ulcer, intestinal tumours, oesophagitis or diverticulosis
  • Hemoglobin lower than 7 g/dL or Creatinin \> 3mg/dL
  • Cerebral-vascular accident
  • Cerebral, medullary and ophthalmological surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pneumology Service. Hospital Clínico

Santiago de Compostela, A Coruña, 15706, Spain

Location

Pneumology Service

Lugo, Lugo, 27004, Spain

Location

Pneumology Service. Hospital Xeral Cies

Vigo, Pontevedra, 36204, Spain

Location

Pneumology Service. Hospital do Meixoeiro

Vigo, Pontevedra, 36214, Spain

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

TinzaparinAcenocoumarolacarboxyprothrombin

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Luis Pérez de Llano, MD

    Complejo Hospitalario Xeral Calde (Lugo)

    STUDY CHAIR

  • Alejandro Veres Racamonde, MD

    Complejo Hospitalario Xeral Calde (Lugo)

    PRINCIPAL INVESTIGATOR

  • Manuel Núnez Delgado, MD

    Hospital do Meixoeiro (Vigo)

    PRINCIPAL INVESTIGATOR

  • Ana Palacios Bartolomé, MD

    Hospital Clínico de Santiago

    PRINCIPAL INVESTIGATOR

  • Virginia Leiro Fernández, MD

    Hospital Xeral (Vigo)

    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

July 3, 2008

First Posted

July 8, 2008

Study Start

April 1, 2005

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

February 13, 2009

Record last verified: 2009-02

Locations

ES(4)