| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00452530 | Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery | PHASE3 | COMPLETED | 3,221 | — | — | Jun 1, 2007 | Jan 1, 2009 | Jul 9, 2014 | 122 | Austria, Belgium +25 |
| NCT00423319 | Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3) | PHASE3 | COMPLETED | 5,407 | — | — | Mar 1, 2007 | Sep 1, 2009 | May 14, 2014 | 143 | United States, Argentina +19 |
Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization.Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.
Event rate=Number of events divided by the number of patients evaluated. A mandatory bilateral ascending contrast venogram was to be obtained on Day 35 (± 3). Patients with confirmed symptomatic DVT at any time, or asymptomatic DVT upon venography, were to receive treatment for DVT according to the investigator's standard of care. Signs and symptoms suggestive of VTE included, but were not limited to: 1) lower extremity DVT: erythema, warmth, pain, swelling, tenderness; and 2) PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended Treatment Period started on day of randomization and, for patients who received treatment, ended at the later of 2 days after last dose of study drug or 38 days after the first dose (presurgery) of study drug. For randomized patients who did not receive study drug, the period ended 38 days after randomization.
| Arm | Type | Description |
|---|---|---|
| Apixaban, 2.5 mg BID + Placebo | EXPERIMENTAL | Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery. |
| Enoxaparin, 40 mg QD + Placebo | ACTIVE_COMPARATOR | Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery. |
| Apixaban, 2.5 mg BID plus placebo | ACTIVE_COMPARATOR | Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD) |
| Enoxaparin, 40 mg QD plus placebo | EXPERIMENTAL | Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID |
| Name | Type | Description |
|---|---|---|
| Enoxaparin | DRUG | 40 mg, administered once daily by subcutaneous injection, for 12 days |
| Apixaban | DRUG | 2.5 mg, administered twice daily as tablets, for 12 days |
| Enoxaparin-matching placebo | DRUG | Administered once daily by subcutaneous injection |
| Apixaban-matching placebo | DRUG | Oral tablet administered twice daily |
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 sus...