Tinzaparin in the Treatment of the Acute Pulmonary Embolism

Acute Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711308
• Other study ID #: EX0401ES
• Secondary ID: eudract-no. 2004
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2008
• Last updated: February 12, 2009
• Start date: April 2005
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Complejo Hospitalario Xeral-Calde
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Embolism
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
Spain	Pneumology Service	Lugo
Spain	Pneumology Service. Hospital Clínico	Santiago de Compostela	A Coruña
Spain	Pneumology Service. Hospital do Meixoeiro	Vigo	Pontevedra
Spain	Pneumology Service. Hospital Xeral Cies	Vigo	Pontevedra

Sponsors (2)

Lead Sponsor	Collaborator
Complejo Hospitalario Xeral-Calde	LEO Pharma

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin		6 months	No
Secondary	direct and indirect cost of each treatment regimen		6 months	No
Secondary	Major haemorrhagic events		6 months	Yes