Last updated: 11/07/2018 15:42:37
Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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 of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications
Trial description: To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants with at least on event of venous thromboembolism (VTE) and/or death from any cause recorded up to Day 47
Timeframe: Baseline to Day 47
Secondary outcomes:
Number of participants with at least one event of venous thromboembolism (VTE) and/or death from any cause recorded up to Day 77
Timeframe: 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
Timeframe: Days 47 and 77
Number of participants who required surgery to treat superficial vein thrombosis recurrence at Days 47 and 77
Timeframe: Days 47 and 77
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77
Timeframe: Days 47 (or last dose plus 4 days) and 77
Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77
Timeframe: Days 47 (or last dose plus 4 days) and 77
Number of any adjudicated bleeding events at Days 47 and 77
Timeframe: Days 47 (or last dose plus 4 days) and 77
Interventions:
Enrollment:
3002
Primary completion date:
2009-31-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Alain Leizorovicz, François Becker, Andrea Buchmüller, Isabelle Quéré, Paolo Prandoni, Hervé Decousus. Clinical relevance of symptomatic superficial-vein thrombosis extension: lessons from the CALISTO study. Blood. 2103;122(10):1724-9.
Decousus H, Prandoni P, Mismetti P, et al;. CALISTO Study Group. Fondaparinux in the treatment of lower-limb superficial-vein thrombosis. . N Engl J Med. 2010;363(13):1222-32.
Medical condition
Thrombosis, Venous
Product
fondaparinux sodium
Collaborators
GSK
Study date(s)
March 2007 to July 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound.
Inclusion and exclusion criteria
Inclusion 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
Trial location(s)
Showing 1 - 6 of 213 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2009-31-07
Actual study completion date
2009-31-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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