Nadroparin for the Initial Treatment of Pulmonary Thromboembolism (NATSPUTE)

This study has been completed.
Sponsor:
Information provided by:
Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT00796692
First received: November 20, 2008
Last updated: November 21, 2008
Last verified: November 2008
  Purpose

Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard, unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are available on the evaluation of body weight adjusted LWMH and standard UFH for the initial treatment of PTE in Chinese population. The aim of this study is to determine whether body weight-adjusted, subcutaneous Nadroparin is as effective and safe as UFH for treatment of patients with objectively documented PTE.


Condition Intervention Phase
Pulmonary Embolism
Thromboembolism
Vascular Diseases
Thrombosis
Drug: Nadroparin
Drug: Unfractionated heparin(UFH)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Body Weight Adjusted Nadroparin vs Standard Unfractionated Heparin for the Initial Treatment of Pulmonary Thromboembolism:a Multi-Centre, Randomised Controlled Trial in China

Resource links provided by NLM:


Further study details as provided by Beijing Chao Yang Hospital:

Primary Outcome Measures:
  • Clinical and image(including V/Q scan and CTPA) improvement [ Time Frame: Time Frame: 14days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrent venous thromboembolism(VTE), major bleeding death Heparin-induced thrombocytopenia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 274
Study Start Date: June 2002
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 2
Low molecular weight heparin
Drug: Nadroparin
LMWH is given with a weight adjusted dose of 86 international anti-factor Xa units of nadroparin (Fraxiparine) per kilogram of body weight(86 anti-factor Xa IU/kg) subcutaneously every 12 hours,which will be used at least 5-7 days.
Other Name: Low moleculor weight hepatin
Active Comparator: Group 1
Unfractionated heparin(UFH)
Drug: Unfractionated heparin(UFH)
UFH is received with an initial bolus dose of 80 IU per kilogram, followed by a continuous intravenous infusion at an initial rate of 18 IU per kilogram per hour. The dose is subsequently adjusted so that the activated partial thromboplastin time (APTT) would be 1.5 to 2.5 times the control value in normal subjects. The tests are performed 4 hours after the start of treatment, whenever a sub-therapeutic APTT had been measured after a dose adjustment, and otherwise daily.UFH will be used at least 5-7 days.
Other Name: Standard Unfractionated heparin

Detailed Description:

Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard, unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are available on the evaluation of body weight adjusted LWMH and standard UFH for the initial treatment of PTE in Chinese population.

The aim of this study is to determine whether body weight-adjusted, subcutaneous Nadroparin is as effective and safe as UFH for treatment of patients with objectively documented PTE.

An open-label, adjudicator-blinded, randomized controlled trial of patients with symptomatic non-massive PTE from 37 major hospitals in China is conducted . Intravenous UFH was administered received an initial bolus dose of 80 IU/kg, followed by a continuous infusion at an initial rate of 18 IU/kg /hour. The dose was subsequently adjusted by activated partial thromboplastin time (APTT) monitoring. LMWH (nadroparin) was administered subcutaneously at a dose of 86 anti-factor Xa IU/kg every 12 hours.

Both treatments were overlapped with at least 3 months of warfarin therapy. Main outcome measures were combined end point of clinical effect, image improvement,Recurrent venous thromboembolism(VTE), major bleeding, and death within 14 days and 3 months of randomization.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 75 years of age
  • Symptomatic non massive PTE confirmed either by a high probability ventilation-perfusion lung scanning (V/Q scan) or by the presence of intraluminal filling defect on spiral computed tomographic pulmonary angiography (CTPA)
  • Haemodynamic stabile, anatomic obstruction no more than 2 lobes on CTPA, or defect no more than 7 segments on V/Q scan,and normal right ventricular function
  • Symptoms within 15 days
  • Written informed consent obtained before randomization.

Exclusion Criteria:

  • Unfractioned heparin anticoagulation for more than 36 hours prior enrollment,
  • Massive PTE or sub-massive PTE requiring thrombolytic therapy or pulmonary embolectomy; Active bleeding or disorders contraindicating anticoagulant therapy
  • Chronic thromboembolism pulmonary hypertension(CTEPH) without evidence of recent episode; Severe hepatic or renal failure
  • Allergy to heparin, other components of Tinzaparin or acenocoumarol,
  • Pregnant status;a life expectancy of less than 3 months;
  • Previous thrombocytopenia induced by heparin
  • Thrombocytopenia < 100000/mm3,
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00796692

  Show 39 Study Locations
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
Principal Investigator: Chen WANG, Prof Beijing Institute of Respiratory Medicine,Beijing Chao Yang Hospital
  More Information

Publications:

Responsible Party: Professor Chen WANG, Beijing Institute of Respiratory Medicine
ClinicalTrials.gov Identifier: NCT00796692     History of Changes
Other Study ID Numbers: 2004BA703B07, 2001BA703B13
Study First Received: November 20, 2008
Last Updated: November 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Beijing Chao Yang Hospital:
Heparin
Low molecular weight heparin
Safety
Efficacy
Cost effective

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Vascular Diseases
Embolism and Thrombosis
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Nadroparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014