Trial | NCT00711308  Report issue

Title

Tinzaparin in the Treatment of the Acute Pulmonary Embolism
Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    102
The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.
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 Started
Apr 30
2005
Primary Completion
Jan 31
2009
Study Completion
Feb 28
2009
Last Update
Feb 13
2009
Estimate

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

tinzaparin Experimental

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

acenocoumarol Active Comparator

tinzaparin followed by acenocoumarol for 6 months

Criteria 

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
No Results Posted