Phase 3
N=3,002
Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
Thrombosis, Venous
Bottom Line
View on ClinicalTrials.gov: NCT00443053 ↗Enrolled (actual)
3,002
Serious AEs
0.9%
Results posted
Aug 2010
Primary outcome: Primary: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 — 13; 88 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fondaparinux 2.5mg or placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 |
13; 88 | <0.001 sig |
| SECONDARY Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77 |
18; 94 | <0.001 sig |
| SECONDARY Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 |
13; 88; 2; 1; 0; 5 | — |
| SECONDARY Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77 |
11; 57; 15; 61 | — |
| SECONDARY Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77 |
1; 1; 2; 1; 1; 1 | — |
| SECONDARY Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77 |
5; 8; 6; 9 | — |
| SECONDARY Number of Any Adjudicated Bleeding Events at Days 47 and 77 |
15; 14; 16; 15 | — |
Summary
To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00443053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.