To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.
Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3,002
Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47
VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.
Time frame: Baseline to Day 47
Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77
VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.
Time frame: Baseline to Day 77
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77
VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within \<=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.
Time frame: Days 47 and 77
Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77
The number of participants requiring surgery was measured.
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GSK Investigational Site
Sofia, Bulgaria
GSK Investigational Site
Brno, Czechia
GSK Investigational Site
Olomouc, Czechia
GSK Investigational Site
Pilsen, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Prague, Czechia
...and 217 more locations
Time frame: Days 47 and 77
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77
Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin \>=20 g/L (1.24 mmol/L); (3) led to a transfusion of \>=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.
Time frame: Days 47 (or last dose plus 4 days) and 77
Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77
Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.
Time frame: Days 47 (or last dose plus 4 days) and 77
Number of Any Adjudicated Bleeding Events at Days 47 and 77
The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.
Time frame: Days 47 (or last dose plus 4 days) and 77