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
  Purpose

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


Condition Intervention Phase
Thrombosis, Venous
Superficial Thrombophlebitis
Drug: Fondaparinux 2.5mg or placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 3002
Study Start Date: March 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fondaparinux 2.5mg Drug: Fondaparinux 2.5mg or placebo
Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
Placebo Comparator: Placebo Drug: Fondaparinux 2.5mg or placebo
Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00443053

  Show 227 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00443053     History of Changes
Other Study ID Numbers: ART108053
Study First Received: March 2, 2007
Results First Received: July 2, 2010
Last Updated: February 7, 2013
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by GlaxoSmithKline:
superficial vein thrombosis
superficial thrombophlebitis
fondaparinux
deep vein thrombosis
venous thromboembolism treatment
thrombosis

Additional relevant MeSH terms:
Thrombophlebitis
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Vasculitis
Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014