Phase 3
N=80
AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
Deep Vein Thrombosis · Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT01780987 ↗Enrolled (actual)
80
Serious AEs
12.7%
Results posted
Jun 2016
Primary outcome: Primary: Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period — 3; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Apixaban (Drug); Unfractionated Heparin (UFH) (Drug); Warfarin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period |
3; 11 | — |
| SECONDARY Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period |
0; 1 | — |
| SECONDARY Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) |
1; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE) |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period |
0; 2 | — |
| SECONDARY Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods |
7; 17 | — |
Summary
The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)
Eligibility Criteria
Inclusion Criteria
- Acute symptomatic proximal DVT with evidence of proximal thrombosis
- Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches
Exclusion Criteria
- Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.
- Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
- Subjects requiring dual anti-platelet therapy
Data sourced from ClinicalTrials.gov (NCT01780987). 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.