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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
The dose of Fondaparinux will be determined based on a subject's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection.
UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.
GSK Investigational Site
Aichi, Japan
The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)
VTE (pulmonary thromboembolism \[PE\] and/or deep vein thromboembolism \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).
Time frame: From Day 1 to Day 90 (±7 days)
The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type)
VTE (pulmonary thromboembolism \[PE\] and/or deep vein thromboembolism \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).
Time frame: From Day 1 to Day 90 (±7 days)
The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse
"Improved," "No change," or "Worse" was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the CIACE.
Time frame: 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
The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).
Time frame: Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)
The Percentage of Participants With a Bleeding Event
Bleeding events (major bleeding \[clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin \>=2 g/dL, or a transfusion \>=2 units\], minor bleeding \[clinically overt bleeding and not adjudicated as major bleeding\]) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).
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GSK Investigational Site
Chiba, Japan
GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Gunma, Japan
GSK Investigational Site
Gunma, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hyōgo, Japan
GSK Investigational Site
Ibaraki, Japan
GSK Investigational Site
Ibaraki, Japan
...and 17 more locations
Time frame: FPX or UFH treatment period (Days 5-10, on average)