Phase 3 N=6,528 Randomized Double-blind Prevention

Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness

Venous Thrombosis · Pulmonary Embolism

Bottom Line

View on ClinicalTrials.gov: NCT00457002 ↗

Enrolled (actual)

6,528

Serious AEs

18.9%

Results posted

May 2014

Primary outcome: Primary: Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population — 2.71; 3.06 Event rate (%) — p=0.4364

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Apixaban (Drug); Enoxaparin (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population	2.71; 3.06	0.4364
PRIMARY Incidence of Major Bleeding During the Treatment Period in Treated Participants	0.47; 0.19	0.0437 sig
PRIMARY Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants	2.26; 1.90	—
PRIMARY Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants	2.67; 2.08	—
PRIMARY Incidence of All Bleeding During the Treatment Period in Treated Participants	7.73; 6.81	—
SECONDARY Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants	1.73; 1.61	—
SECONDARY Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants	1.66; 1.51	—
SECONDARY Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period	6.44; 6.63	—
SECONDARY Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period	6.44; 6.50	—
SECONDARY Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period	2.71; 2.93	—
SECONDARY Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants	0.06; 0.09	—
SECONDARY Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period	3.11; 3.46	—
SECONDARY Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period	0.40; 0.80	—
SECONDARY Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period	7.16; 6.83	—
SECONDARY Incidence of Adjudicated PE With Onset During the Intended Treatment Period	0.22; 0.24	—
SECONDARY Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period	0.22; 0.24	—
SECONDARY Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period	0.15; 0.49	—
SECONDARY Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period	2.40; 2.50	—
SECONDARY Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period	0.00; 0.15	—
SECONDARY Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period	0.15; 0.37	—
SECONDARY Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period	2.36; 2.12	—
SECONDARY Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants	1871; 1910; 611; 601; 244; 221	—
SECONDARY Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period	-1.0; -0.4; 0.0; -0.5	—
SECONDARY Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period	-3.0; -2.4; -2.3; -2.9	—
SECONDARY Mean Change From Baseline in Heart Rate in Treated Participants	-5.4; -5.1; -4.0; -4.3	—
SECONDARY Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants	133; 98; 23; 17; 9; 7	—
SECONDARY Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants	6; 8; 3; 3; 25; 25	—
SECONDARY Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants	35; 47; 23; 33; 24; 29	—
SECONDARY Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants	5; 3; 39; 30; 78; 51	—
SECONDARY Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants	0.38; 0.37; 0.22; 0.12; 0.16; 0.25	—
SECONDARY Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements	45; 42; 5; 1; 127; 142	—
SECONDARY Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants	23; 28; 22; 32; 14; 13	—

Summary

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Eligibility Criteria

Inclusion Criteria

men and non-pregnant, non-breastfeeding women
40 years or older
hospitalized with congestive heart failure or acute respiratory failure
infection (without septic shock)
acute rheumatic disorder
inflammatory bowel disease

Exclusion Criteria

patients with venous thromboembolism (VTE)
active bleeding or at high risk of bleeding
unable to take oral medication
with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00457002). 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.