Nadroparin for the Initial Treatment of Pulmonary Thromboembolism (NATSPUTE)
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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 |
- Clinical and image(including V/Q scan and CTPA) improvement [ Time Frame: Time Frame: 14days ] [ Designated as safety issue: No ]
- 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 |
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
Show 39 Study Locations| 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 June 18, 2013