Clincosm LogoSign in Get a demo

Tinzaparin in the Treatment of the Acute Pulmonary Embolism

Sponsor
Complejo Hospitalario Xeral-Calde (Other)
Overall Status
Completed
CT.gov ID
NCT00711308
Collaborator
LEO Pharma (Industry)
102
Enrollment
4
Locations
2
Arms
46.1
Duration (Months)
25.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 6 months in patients with acute venous thrombosis.

To evaluate the direct and indirect cost of each treatment regimen in a rural population environment.

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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
tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
Other Names:
  • innohep

    		•
    Active Comparator: acenocoumarol

    tinzaparin followed by acenocoumarol for 6 months

    Drug: tinzaparin
    tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
    Other Names:
  • innohep

    • Drug: acenocoumarol
    acenocoumarol for 6 months
    Other Names:
  • vitamin K antagonist

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin [6 months]

    Secondary Outcome Measures

    1. direct and indirect cost of each treatment regimen [6 months]

    2. Major haemorrhagic events [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pneumology Service. Hospital Clínico Santiago de Compostela A Coruña Spain 15706
    2 Pneumology Service. Hospital Xeral Cies Vigo Pontevedra Spain 36204
    3 Pneumology Service. Hospital do Meixoeiro Vigo Pontevedra Spain 36214
    4 Pneumology Service Lugo Spain 27004

    Sponsors and Collaborators

    • Complejo Hospitalario Xeral-Calde
    • LEO Pharma

    Investigators

    • Study Chair: Luis Pérez de Llano, MD, Complejo Hospitalario Xeral Calde (Lugo)
    • Principal Investigator: 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)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00711308
    Other Study ID Numbers:
    • EX0401ES
    • eudract-no. 2004-002019-97
    First Posted:
    Jul 8, 2008
    Last Update Posted:
    Feb 13, 2009
    Last Verified:
    Feb 1, 2009
    Keywords provided by , ,
    pulmonary embolism
    low molecular weight heparin
    vitamin K antagonist
    Longterm
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Embolism
    Vitamin K
    Tinzaparin
    Heparin, Low-Molecular-Weight
    Dalteparin
    Acenocoumarol

    Study Results

    No Results Posted as of Feb 13, 2009