Phase 3
Completed N=5,395
Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Source: ClinicalTrials.gov NCT00643201 ↗Enrolled (actual)
5,395
Serious AEs
15.4%
Results posted
Apr 2014
Primary outcomePrimary: 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
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)
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 | — |
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
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. Informational only — not medical advice.