Tinzaparin in the Treatment of the Acute Pulmonary Embolism
This study has been completed.
Sponsor:
Complejo Hospitalario Xeral-Calde
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
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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:
|
|
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:
Drug: acenocoumarol
acenocoumarol for 6 months
Other Names:
|
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
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 Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Acenocoumarol Heparin, Low-Molecular-Weight Vitamin K Tinzaparin Vitamins Anticoagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Micronutrients Growth Substances Physiological Effects of Drugs Antifibrinolytic Agents Hemostatics Coagulants |
ClinicalTrials.gov processed this record on May 16, 2013