Tinzaparin in the Treatment of the Acute Pulmonary Embolism

This study has been completed.
Sponsor:
Collaborator:
LEO Pharma
Information provided by:
Complejo Hospitalario Xeral-Calde
ClinicalTrials.gov Identifier:
NCT00711308
First received: July 3, 2008
Last updated: February 12, 2009
Last verified: February 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • direct and indirect cost of each treatment regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Major haemorrhagic events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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 Names:
  • tinzaparin
  • 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:
  • tinzaparin
  • innohep
Drug: acenocoumarol
acenocoumarol for 6 months
Other Names:
  • acenocoumarol
  • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711308

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

No publications provided

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
Study First Received: July 3, 2008
Last Updated: February 12, 2009
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Acenocoumarol
Tinzaparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014