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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00443053
First received: March 2, 2007
Last updated: February 7, 2013
Last verified: February 2012

March 2, 2007
February 7, 2013
March 2007
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT00443053 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
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.
Not Provided
Not Provided
 
Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
See Detailed Description

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Thrombosis, Venous
  • Superficial Thrombophlebitis
Drug: Fondaparinux 2.5mg or placebo
Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
  • Active Comparator: Fondaparinux 2.5mg
    Intervention: Drug: Fondaparinux 2.5mg or placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Fondaparinux 2.5mg or placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3002
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound.

Exclusion criteria:

  • Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
  • deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism within last 6 months, treatment for cancer during last 6 months,
  • anticoagulant medication for more than 48 hours prior to inclusion,
  • need for oral non-steroidal anti-inflammatory drugs during the study, significant bleeding event during past month,
  • major surgery within last 3 months, low platelet count (below 100×109/L),
  • kidney disease (Calculated creatinine clearance < 30 mL/min), woman of child-bearing potential not using reliable contraceptive method
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Czech Republic,   Estonia,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Latvia,   Netherlands,   Poland,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Ukraine
 
NCT00443053
ART108053
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP