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Tinzaparin in the Treatment of the Acute Pulmonary Embolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00711308
First Posted: July 8, 2008
Last Update Posted: February 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
LEO Pharma
Information provided by:
Complejo Hospitalario Xeral-Calde
  Purpose
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 Intervention Phase
Acute Pulmonary Embolism Drug: tinzaparin Drug: acenocoumarol Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Complejo Hospitalario Xeral-Calde:

Primary Outcome Measures:
  • Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • direct and indirect cost of each treatment regimen [ Time Frame: 6 months ]
  • Major haemorrhagic events [ Time Frame: 6 months ]

Enrollment: 102
Study Start Date: April 2005
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: innohep
Drug: acenocoumarol
acenocoumarol for 6 months
Other Name: vitamin K antagonist

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711308


Locations
Spain
Pneumology Service. Hospital Clínico
Santiago de Compostela, A Coruña, Spain, 15706
Pneumology Service. Hospital Xeral Cies
Vigo, Pontevedra, Spain, 36204
Pneumology Service. Hospital do Meixoeiro
Vigo, Pontevedra, Spain, 36214
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)
  More Information

Responsible Party: Pérez de Llano, Luis MD, Pneumology Service, Complejo Hospitalario Xeral-Calde
ClinicalTrials.gov Identifier: NCT00711308     History of Changes
Other Study ID Numbers: EX0401ES
eudract-no. 2004-002019-97
First Submitted: July 3, 2008
First Posted: July 8, 2008
Last Update Posted: February 13, 2009
Last Verified: February 2009

Keywords provided by Complejo Hospitalario Xeral-Calde:
pulmonary embolism
low molecular weight heparin
vitamin K antagonist
Longterm

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vitamins
Vitamin K
Tinzaparin
Acenocoumarol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Fibrinolytic Agents
Anticoagulants