Clinical Trial: Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment

Brief Summary: To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

Detailed Summary: 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
Sponsor: GlaxoSmithKline

Current Primary Outcome: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 [ Time Frame: Baseline to Day 47 ]

Original Primary Outcome: Symptomatic venous thromboembolism (VTE) and/or death up to Day 45. VTE is defined in this study as any of the following symptomatic events: pulmonary embolism, deep-vein thrombosis or recurrence or extension of superficial thrombophlebitis.

Current Secondary Outcome:

• Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77 [ Time Frame: Baseline 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.
• Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 [ Time Frame: Days 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.
• Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77 [ Time Frame: Days 47 and 77 ]
  The number of participants requiring surgery was measured.
• Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77 [ Time Frame: Days 47 (or last dose plus 4 days) 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.
• Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77 [ Time Frame: Days 47 (or last dose plus 4 days) 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.
• Number of Any Adjudicated Bleeding Events at Days 47 and 77 [ Time Frame: Days 47 (or last dose plus 4 days) 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.

Original Secondary Outcome: Symptomatic venous thrombolism and/or death up to Day 75. Each of the individual events making up venous thromboembolism up to Day 45 and up to Day 75. Bleeding events and arterial thromboembolic events up to Day 45 and up to Day 75.

Information By: GlaxoSmithKline

Dates:
Date Received: March 2, 2007
Date Started: March 2007
Date Completion:
Last Updated: January 20, 2017
Last Verified: January 2017