Phase 3
N=3,195
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
Deep Vein Thrombosis · Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT00371683 ↗Enrolled (actual)
3,195
Serious AEs
7.7%
Results posted
Dec 2015
Primary outcome: Primary: Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects — 8.99; 8.85 percentage of participants — p=0.0635
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Enoxaparin + Placebo (Drug); Apixaban + Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects |
8.99; 8.85 | 0.0635 |
| PRIMARY Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population |
0.69; 1.39; 2.19; 2.96; 2.88; 4.28 | 0.0533 |
| PRIMARY Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period |
0.13; 0.13; 0.26; 0.45; 0.38; 0.58 | — |
| SECONDARY Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period |
2.05; 1.64 | 0.7779 |
| SECONDARY Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period |
8.91; 8.61 | 0.7754 |
| SECONDARY Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period |
1.97; 1.40 | 0.2626 |
| SECONDARY Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period |
2.13; 1.97 | 0.7700 |
| SECONDARY Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period |
2.05; 1.73 | 0.5443 |
| SECONDARY Event Rate for Participants With All-Cause Death During the Intended Treatment Period |
0.19; 0.19 | 0.9975 |
| SECONDARY Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period |
0.13; 0.00 | 0.1578 |
| SECONDARY Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period |
1.25; 1.00 | — |
| SECONDARY Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period |
1.19; 0.81 | 0.2873 |
| SECONDARY Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period |
9.90; 10.60 | 0.6145 |
| SECONDARY Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period |
1.00; 0.44; 0.88; 0.44; 7.79; 8.20 | — |
| SECONDARY Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period |
0.72; 0.91; 7.24; 8.03; 0.56; 0.66 | — |
| SECONDARY Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period |
0.06; 0.31; 0.06; 0.25; 0.00; 0.13 | — |
| SECONDARY Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period |
0.06; 0.06; 0.06; 0.06; 0.00; 0.00 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population |
123; 123; 110; 144; 60; 58 | — |
| SECONDARY Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period |
-0.4; -0.9; 1.7; 1.5; 2.3; 2.1 | — |
| SECONDARY Mean Change From Baseline in Heart Rate During the Treatment Period |
2.3; 2.7; 4.6; 4.5; 4.5; 5.0 | — |
| SECONDARY Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period |
386; 392; 135; 157; 6; 9 | — |
| SECONDARY Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period |
42; 55; 33; 45; 29; 40 | — |
| SECONDARY Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period |
1; 5; 0; 1; 11; 17 | — |
| SECONDARY Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period |
8; 5; 54; 28; 527; 513 | — |
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 after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.
Eligibility Criteria
Key Inclusion Criteria
- Men and non-pregnant, non-breastfeeding women
- 18 years or older
- Scheduled for knee replacement surgery
Key Exclusion Criteria
- hereditary or acquired bleeding disorders
- clotting disorders
- bleeding or high risk for bleeding
- drugs that affect bleeding or coagulation
- need for ongoing parenteral or oral anticoagulation
Data sourced from ClinicalTrials.gov (NCT00371683). 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.