Phase 2
Completed N=218
A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
Source: ClinicalTrials.gov NCT00787150 ↗Enrolled (actual)
218
Serious AEs
4.6%
Results posted
Mar 2013
Primary outcomePrimary: Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period — 4; 1; 1 participants
Summary
To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period |
4; 1; 1 | — |
| SECONDARY Number of Participants With Total Bleeding Events During the Treatment Period |
13; 9; 17 | — |
| SECONDARY Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period |
1; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period |
3; 1; 1 | — |
| SECONDARY Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period |
3; 0; 0 | — |
| SECONDARY Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period |
3; 0; 0 | — |
| SECONDARY Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 20 years outpatient (regardless of sex)
- Patients diagnosed as non-valvular atrial fibrillation (NVAF)
- One or more following risks of stroke.
Exclusion Criteria
- Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
- Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
- Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.
Data sourced from ClinicalTrials.gov (NCT00787150). 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.