Phase 3 Completed N=3,057 Randomized Double-blind Treatment

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

Deep Vein Thrombosis · Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT00452530 ↗

Enrolled (actual)

3,057

Serious AEs

5.3%

Results posted

May 2014

Primary outcomePrimary: Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period — 15.06; 24.37 Percentage of events/patients evaluated — p=<0.0001

Summary

The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period	15.06; 24.37	<0.0001 sig
SECONDARY Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period	1.09; 2.17	0.0003 sig
SECONDARY Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM	0.60; 0.93; 2.93; 3.85; 3.53; 4.77	0.3014
SECONDARY Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome	72; 88; 90; 112; 40; 44	—

Eligibility Criteria

Key Inclusion Criteria

Patients scheduled for either elective unilateral or same-day bilateral total knee replacement surgery (TKR) or a revision of at least 1 component of a TKR
Patients willing and able to undergo bilateral ascending contrast venography

Key Exclusion Criteria

Known or suspected hereditary or acquired bleeding or coagulation disorders in the participant or his or her first-degree relative
Known or suspected history of heparin-induced thrombocytopenia
Known coagulopathy
Active bleeding or at high risk for bleeding
Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
Active hepatobiliary disease
Alcohol and/or substance abuse within the past year
Any condition for which, in the opinion of the investigator, surgery or administration of an anticoagulant was contraindicated
Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure >180 mm Hg or supine diastolic blood pressure >105 mm Hg
Clinically significant laboratory abnormalities at the enrollment visit:
Hemoglobin 2*upper limit of normal (ULN) or a total bilirubin ≥1.5*ULN (unless an alternative causative factor such as Gilbert's syndrome was identified)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00452530). 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.