Phase 3
Completed 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
Source: ClinicalTrials.gov NCT00443053 ↗
Enrolled (actual)
3,002
Serious AEs
0.9%
Results posted
Aug 2010
Primary outcomePrimary: 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
Summary
To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.
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 | — |
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. Informational only — not medical advice.