Phase 3
Completed N=5,598
A Phase III Study of Apixaban in Patients With Atrial Fibrillation
Source: ClinicalTrials.gov NCT00496769 ↗Enrolled (actual)
5,598
Serious AEs
30.4%
Results posted
Nov 2013
Primary outcomePrimary: Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period — 1.62; 3.63 Percentage of events — p=<0.00001
Summary
The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period |
1.62; 3.63 | <0.00001 sig |
| SECONDARY Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period |
4.21; 6.35 | 0.00026 sig |
| SECONDARY Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death |
3.51; 4.42; 5.23; 7.13; 2.65; 3.03 | 0.06782 |
| SECONDARY Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period |
1.41; 0.92; 4.46; 3.24; 10.85; 8.32 | 0.0716 |
| SECONDARY Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period |
10.85; 8.32 | 0.0017 sig |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome |
1833; 1925; 657; 804; 281; 259 | — |
| SECONDARY Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality |
131; 120; 0; 0; 13; 9 | — |
| SECONDARY Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued) |
0; 0; 13; 25; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued) |
0; 0; 13; 25; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Male and female
- Age of 50 years or older
- Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)
- At least 1 of the following risk factors for stroke:
- Prior stroke or transient ischemic attack
- Age of 75 years or older
- Arterial hypertension on treatment
- Diabetes mellitus
- Heart failure (New York Health Authority Class 2 or greater at time of enrollment)
- Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment
- Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio 2.5 mg/dL or a calculated creatinine clearance 2 times upper limit of normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative causative factor [such as Gilbert's syndrome] is identified)
- Allergy or adverse reaction to acetylsalicylic acid
- Required treatment with a thienopyridine (clopidogrel or ticlopidine)
- Prisoners or participants who are compulsory detained (involuntarily incarcerated)
- Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study
- Patients who are compulsorily detained for treatment for a psychiatric or physical illness
Data sourced from ClinicalTrials.gov (NCT00496769). 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.