Last updated: 11/07/2018 01:22:53
The treatment of Acute Pulmonary Thromboembolism (PE) of GSK576428 (Fondaparinux Sodium) in Japanese patients
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE)
Trial description: The primary objective is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and Deep Vein Thrombosis [DVT])) and safety of GSK576428 as the initial treatment in subjects with acute PE in an open-label design.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
The percentage of participants with recurrent or new symptomatic venous thromboembolism (VTE)
Timeframe: From Day 1 to Day 90 (±7 days)
Secondary outcomes:
The percentage of participants with recurrent or new symptomatic/asymptomatic venous thromboembolism (VTE) (by type)
Timeframe: From Day 1 to Day 90 (±7 days)
The percentage of participants with perfusion lung scan results scored as improved, no change, or worse
Timeframe: Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)
Total perfusion score at baseline and mean change from baseline at Days 5-10
Timeframe: Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)
The percentage of participants with a bleeding event
Timeframe: FPX or UFH treatment period (Days 5-10, on average)
Interventions:
Drug: Fondaparinux sodium
Drug: unfractionated heparin (UFH)
Enrollment:
41
Observational study model:
Not applicable
Primary completion date:
2008-10-12
Time perspective:
Not applicable
Clinical publications:
Mashio Nakamura, Yoshiaki Okano, Hiroki Minamiguchi, Mitsuru Munemasa, Masahiro Sonoda, Norikazu Yamada, Kazuhiko Hanzawa, Narumi Aoyagi, Hiroshi Tsujimoto, Nobuaki Sarai, Hiromu Nakajima,Takeyoshi Kunieda. Multidetector-Row Computed Tomography-Based Clinical Assessment of Fondaparinux for Treatment of Acute Pulmonary Embolism and Acute Deep Vein Thrombosis in Japanese Patients. [Circ J]. 2011;75:1424.
Mashio Nakamura, Yoshiaki Okano, Hiroki Minamiguchi, Mitsuru Munemasa, Masahiro Sonoda, Norikazu Yamada, Kazuhiko Hanzawa, Narumi Aoyagi, Hiroshi Tsujimoto, Nobuaki Sarai, Hiromu Nakajima,Takeyoshi Kunieda.Multidetector-Row Computed Tomography-Based Clinical Assessment of Fondaparinux for Treatment of Acute Pulmonary Embolism and Acute Deep Vein Thrombosis in Japanese Patients.Circ J.2011;75(6):1424-32
Medical condition
Embolism, Pulmonary
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
July 2007 to December 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
- Subjects with a confirmed diagnosis (by Multi detector-row CT [MDCT]) of acute symptomatic PE who are hemodynamically stable (i.e., the condition where anticoagulant therapy alone are indicated) (the time from onset should be no longer than 5 days, and subjects with or without symptomatic DVT are eligible)
- Age: >=20 years
- Shock or hemodynamic instability*.
- *: Defined as shock or decreased blood pressure (systolic blood pressure <90 mmHg or >=40 mmHg) lasting for at least 15 minutes and does not represent hemodynamically unstable conditions due to newly emergent arrhythmia, dehydration or sepsis.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with a confirmed diagnosis (by Multi detector-row CT [MDCT]) of acute symptomatic PE who are hemodynamically stable (i.e., the condition where anticoagulant therapy alone are indicated) (the time from onset should be no longer than 5 days, and subjects with or without symptomatic DVT are eligible)
- Age: >=20 years
- Gender: No restriction Female subjects must either be of non-childbearing potential (post-menopausal >1 year, hysterectomy, or sterilization), or of childbearing potential, has a negative pregnancy test at screening, and agree to use contraception throughout the study period.
- Hospitalization status: Subjects who are able to stay at the hospital at least during the initial treatment period.
- Written informed consent from the subject him/herself or his/her legally acceptable representative. Written informed consent from the subject's legally acceptable representative must be obtained if the subject is incapable of giving consent.
Exclusion criteria:
- Shock or hemodynamic instability*. *: Defined as shock or decreased blood pressure (systolic blood pressure <90 mmHg or >=40 mmHg) lasting for at least 15 minutes and does not represent hemodynamically unstable conditions due to newly emergent arrhythmia, dehydration or sepsis.
- Right cardiac function failure detected by echocardiography at screening.
- Requirement for surgical thrombectomy, catheter intervention and thrombolytic therapy for the current PE.
- Subjects (for example, with free-floating thrombus in the femoral vein or ilium by MDCT at screening) for whom insertion of inferior vena cava filter is indicated or subjects in whom inferior vena cava filter is present.
- Prior to entry into the study, therapeutic dosage of anticoagulants for more than 24 hours to treat the current episode.
- Active, clinically significant bleeding
- Thrombocytopenia (platelet count <10×10⁴/µL at screening)
- Concurrent conditions with bleeding risk (e.g., ulcer of the gastrointestinal tract, diverticulitis of the gastrointestinal tract, colitis, acute bacterial endocarditis, severe hypertension*, or severe diabetes) or bleeding tendency. *: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
- Severe hepatic disorder
- Known hypersensitivity to heparin, low-molecular-weight heparin (LMWH) or warfarin
- Previous history of cerebral hemorrhage
- Brain, spinal, or ophthalmological surgery within 3 months prior to entry into this study
- Previous history of Heparin-induced thrombocytopenia
- Patients for whom anticoagulant therapy is contraindicated or who cannot be taken off anticoagulant therapy due to coexistent condition (e.g. prosthetic heart valve implant).
- Severe renal disorder (serum creatinine >2.0 mg/dL [180 µmol/L] at screening) in a well hydrated subject
- Documented hypersensitivity to contrast media
- Use of any contraindicated drug that cannot be combined with the injection of contrast medium [e.g., antihyperglycemic metformin hydrochloride (Glycoran®, Melbin®)]
- Participation in any other therapeutic drug study or a clinical study within 6 months prior to entry into this study
- Previous participation in a study of GSK576428
- Drug or alcohol abuse
- Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
- Recent surgery within 3 days prior to entry into the study
- Life expectancy <3 months
- Pregnant women, nursing mothers, women who may be pregnant, or women contemplating pregnancy during the study period
- Others whom the investigator or subinvestigator considers not eligible for the study
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-10-12
Actual study completion date
2008-10-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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