Tinzaparin in the Treatment of the Acute Pulmonary Embolism

Overview

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

Full Title of Study: “Long Term Subcutaneous Tinzaparin Compared With Tinzaparin and Oral Anticoagulants in the Treatment of the Acute Pulmonary Embolism”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2009

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: tinzaparin
    • tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months
  • Active Comparator: acenocoumarol
    • tinzaparin followed by acenocoumarol for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin
    • Time Frame: 6 months

Secondary Measures

  • direct and indirect cost of each treatment regimen
    • Time Frame: 6 months
  • Major haemorrhagic events
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Complejo Hospitalario Xeral-Calde
  • Collaborator
    • LEO Pharma
  • Provider of Information About this Clinical Study
    • Pérez de Llano, Luis MD, Pneumology Service, Complejo Hospitalario Xeral-Calde
  • Overall Official(s)
    • Luis Pérez de Llano, MD, Study Chair, Complejo Hospitalario Xeral Calde (Lugo)
    • Alejandro Veres Racamonde, MD, Principal Investigator, Complejo Hospitalario Xeral Calde (Lugo)
    • Manuel Núnez Delgado, MD, Principal Investigator, Hospital do Meixoeiro (Vigo)
    • Ana Palacios Bartolomé, MD, Principal Investigator, Hospital Clínico de Santiago
    • Virginia Leiro Fernández, MD, Principal Investigator, Hospital Xeral (Vigo)

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