Phase 3 N=2,482 Randomized Double-blind Treatment

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

Venous Thrombosis

Bottom Line

View on ClinicalTrials.gov: NCT00633893 ↗

Enrolled (actual)

2,482

Serious AEs

15.2%

Results posted

Oct 2013

Primary outcome: Primary: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation — 0.0381; 0.0418; 0.1158 Proportion of participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Apixaban (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation	0.0381; 0.0418; 0.1158	<0.0001 sig
PRIMARY Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation	0.0226; 0.0172; 0.0929	<0.0001 sig
SECONDARY Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation	0.0321; 0.0418; 0.1110	<0.0001 sig
SECONDARY Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation	0.0321; 0.0418; 0.1146	<0.0001 sig
SECONDARY Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation	0.0226; 0.0344; 0.0869	<0.0001 sig
SECONDARY Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation	0.0274; 0.0308; 0.0446	0.1084
SECONDARY Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation	0.0202; 0.0295; 0.0314	0.3059
SECONDARY Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation	0.0202; 0.0295; 0.0350	0.1316
SECONDARY Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation	0.0262; 0.0308; 0.0398	0.2361
SECONDARY Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation	6; 7; 53; 7; 4; 13	—
SECONDARY Adjudicated Major Bleeding During the Treatment Period - Treated Population	0.0024; 0.0012; 0.0048	0.3925
SECONDARY Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants	0.0321; 0.0432; 0.0266	0.5148
SECONDARY Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants	0.0298; 0.0419; 0.0230	0.3932
SECONDARY Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants	0.0893; 0.1208; 0.0702	0.1691
SECONDARY Adjudicated Total Bleeding During the Treatment Period - Treated Participants	0.1119; 0.1492; 0.0896	0.1466
SECONDARY Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation	0.0167; 0.0172; 0.0881	—
SECONDARY Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation	0.0167; 0.0172; 0.0917	—
SECONDARY Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation	0.0071; 0.0098; 0.0639	—
SECONDARY Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation	0.0095; 0.0049; 0.0181	—
SECONDARY Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation	0.0024; 0.0037; 0.0084	—
SECONDARY Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation	0.0024; 0.0037; 0.0121	—
SECONDARY Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation	0.0083; 0.0049; 0.0169	—

Summary

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Eligibility Criteria

Inclusion Criteria

Men and women ≥ 18 years of age;
Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
Anticoagulant treatment completed
No recurrence of Venous Thromboembolism (VTE)

Exclusion Criteria

Subjects with indications for long-term treatment with a vitamin K antagonist
Active bleeding or high risk for serious bleeding
Short life expectancy
Uncontrolled high blood pressure
Impaired kidney or liver function

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00633893). 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.