Phase 3 N=5,395 Randomized Double-blind Treatment

Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Venous Thrombosis

Bottom Line

View on ClinicalTrials.gov: NCT00643201 ↗

Enrolled (actual)

5,395

Serious AEs

15.4%

Results posted

Apr 2014

Primary outcome: Primary: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment — 0.0226; 0.0269 proportion of participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Enoxaparin (Drug); warfarin (Drug); Placebo for apixaban (Drug); Placebo for enoxaparin (Drug); Placebo for warfarin (Drug); apixaban (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment	0.0226; 0.0269	<0.0001 sig
SECONDARY Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death	0.0322; 0.0395	0.1554
SECONDARY Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death	0.0234; 0.0292	0.1848
SECONDARY Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding	0.0280; 0.0448	0.0011 sig
SECONDARY Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding	0.0699; 0.1261	<0.0001 sig
SECONDARY Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period	0.0084; 0.0133	—
SECONDARY Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period	0.0104; 0.0095	—
SECONDARY Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period	0.0046; 0.0061	—
SECONDARY Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period	0.0058; 0.0087	—
SECONDARY Incidence of All-Cause Death During the Intended Treatment Period	0.0157; 0.0198	—
SECONDARY Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants	0.0056; 0.0182	<0.0001 sig
SECONDARY Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants	0.0430; 0.0971	<0.0001 sig
SECONDARY Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants	0.0385; 0.0800	<0.0001 sig
SECONDARY Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants	0.1170; 0.1878	<0.0001 sig
SECONDARY Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants	0.1502; 0.2514	<0.0001 sig
SECONDARY Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants	1795; 1923; 417; 410; 415; 695	—
SECONDARY Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests	23; 17; 26; 20; 96; 101	—
SECONDARY Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests	44; 31; 17; 11; 3; 10	—
SECONDARY Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests	2; 7; 47; 37; 52; 145	—
SECONDARY Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests	20; 24; 6; 3; 15; 16	—
SECONDARY Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests	85; 127; 46; 31; 105; 102	—

Summary

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Eligibility Criteria

Inclusion Criteria

Men and women ≥ 18 years of age
Clinical diagnosis of DVT or PE

Exclusion Criteria

Contraindications for enoxaparin or warfarin
Active bleeding or high risk for serious bleeding
Short life expectancy
Uncontrolled high blood pressure
Significantly impaired kidney or liver function

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00643201). 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.