Phase 3 N=18,201 Randomized Double-blind Prevention

Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation

Atrial Fibrillation · Atrial Flutter

Bottom Line

View on ClinicalTrials.gov: NCT00412984 ↗

Enrolled (actual)

18,201

Serious AEs

35.7%

Results posted

Apr 2013

Primary outcome: Primary: Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period — 159; 173; 38; 76 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: warfarin (Drug); apixaban (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period	159; 173; 38; 76; 15; 16	—
PRIMARY Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period	1.27; 1.60	0.0114 sig
SECONDARY Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period	327; 462	—
SECONDARY Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period	2.13; 3.09	<.0001 sig
SECONDARY Number of Participants With Events of All-Cause Death During the Intended Treatment Period	603; 669	—
SECONDARY Rate of Adjudicated All-Cause Death During the Intended Treatment Period	3.52; 3.94	0.0465 sig
SECONDARY Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period	0.97; 1.05; 0.24; 0.47; 0.09; 0.10	0.4220
SECONDARY Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period	3.17; 4.11; 4.49; 5.04; 6.13; 7.20	<.0001 sig
SECONDARY Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period	229; 285	—
SECONDARY Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period	3.21; 4.06	0.0098 sig
SECONDARY Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period	613; 877	—
SECONDARY Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period	4.07; 6.01	<.0001 sig
SECONDARY Number of Participants With All Bleeding Events During Treatment Period	2356; 3060	—
SECONDARY Rate of All Bleeding Events During Treatment Period	18.08; 25.82	<.0001 sig

Summary

The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Eligibility Criteria

Inclusion Criteria

Males and females ≥ 18 yrs with atrial fibrillation (AF) and one or more of the following risk factors for stroke:
Age ≥ 75, previous stroke
transient ischemic attack (TIA) or Systemic Embolism (SE)
Symptomatic congestive heart failure or left ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 40%
Diabetes mellitus or hypertension requiring pharmacological treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00412984). 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.