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Table summary of clinical trials for apixaban back     pdf    short list

Clinical trials of apixaban (BMS 562247, BMS562247, BMS-562247, Eliquis, ) are available for the clinical conditions:


DVT prophylaxis

These trials are included in meta-analysis concerning: new oral anticoagulants in all type of patients, direct factor Xa inhibitors in all type of patients, new oral anticoagulants in orthopaedic surgery, anticoagulant in orthopedic surgery, antithrombotics in orthopedic surgery, new oral anticoagulants in elective major knee surgery, antithrombotics in elective major knee surgery, antithrombotics in patients with cancer, antithrombotics in elective hip replacement, new oral anticoagulants in elective hip replacement, antithrombotics in medical patients, new oral anticoagulants in medical patients,

apixaban vs placebo
CV185-027 (ongoing)
NCT00320255
apixaban
versus
Patients undergoing treatment for advanced cancer  Follow-up:
double blind
 
apixaban vs enoxaparin
ADVANCE 3 ,2010
NCT00423319
apixaban 2.5mg twice daily for 35 days
versus
enoxaparin 40mg once daily for 35 days
patients undergoing elective total hip replacement surgery  Follow-up: 35 days (+60)
double blind
21 countries 
ADOPT ,2011
NCT00457002
apixaban 2.5mg twice daily, 30 days
versus
enoxaparin 40mg once daily 6-14 days
acutely ill patients who had congestive heart failure or respiratory failure or other medical disorders and at least one additional risk factor for venous thromboembolism and who were hospitalized with an expected stay of at least 3 days   Follow-up: 30 days
double blind
 
apixaban vs enoxaparin (europe regimen)
ADVANCE 2 ,2010
NCT00452530
apixaban 2.5mg twice daily during 12 days
versus
enoxaparin 40mg once daily 12 days
patients undergoing elective unilateral or bilateral total knee replacement  Follow-up: 12 days
double blind
27 countries 
apixaban vs enoxaparin (US regimen)
APROPOS 2.5mg ,2007
NCT00097357
apixaban 2.5mg BID for 12 days
versus
enoxaparin 30mg twice daily for 12 days
patients undergoing elective total knee replacement surgery  Follow-up: 12 days
double blind
 
ADVANCE-1 ,2008
NCT00371683
apixaban 2.5 mg orally twice daily for 10 to 14 days
versus
enoxaparin 30mg subcutaneously every 12 hours for 10-14 days
patients undergoing knee-replacement surgery  Follow-up: 10-14 days
double blind
14 countries 

Acute coronary syndrome

These trials are included in meta-analysis concerning: antithrombotics in all type of patient, anticoagulant in All ACS (including AMI), direct factor Xa inhibitors in all type of patients, antithrombotics in patients with a recent ACS, new oral anticoagulants in all type of patients,

apixaban vs placebo
APPRAISE-1 (10mg od) ,2009
NCT00313300
apixaban 10 mg once daily
versus
placebo
patients with a recent ST-elevation or non–ST-elevation acute coronary syndrome(<7 days)   Follow-up: 6 months
double blind
Europe, Middle East, North America 
APPRAISE-1 (2.5 mg bid) ,2009
NCT00313300
Apixaban 2.5mg twice daily
versus
placebo
patients with a recent ST-elevation or non–ST-elevation acute coronary syndrome(<7 days)   Follow-up: 6 months
double blind
Europe, Middle East, North America 
APPRAISE 2 ,2011
NCT00831441
apixaban 5mg twice daily
versus
placebo
patients with a recent acute coronary syndrome and at least two additional risk factors for recurrent ischemic events  Follow-up: 8 months
double blind
39 countries 
APPRAISE japan (ongoing)
NCT00852397
2 doses of apixaban (2.5 mg BID and 5.0 mg BID) for 24 weeks in combination with standard therapy (aspirin and /or additional antiplatelet therapy)
versus
placebo
patients with recent (<=7 days) acute coronary syndrome  Follow-up:
double-blind
Japan 

Venous thrombosis

These trials are included in meta-analysis concerning: antithrombotics in all type of patients, new oral anticoagulants in all types of patients, antithrombotics in secondary prevention of VTE,

apixaban 2.5mg vs discontinuation
AMPLIFY-EXT 2.5mg ,2012
NCT00633893
Extended Treatment with apixaban 2.5 mg twice daily 12 months
versus
placebo
patients who have completed their intended treatment for deep vein thrombosis or pulmonary embolism   Follow-up: 12 mo
double blind
 
AMPLIFY-EXT 5mg ,2012
NCT00633893
Extended Treatment with apixaban 5 mg twice daily 12 months
versus
placebo
patients who have completed their intended treatment for deep vein thrombosis or pulmonary embolism   Follow-up: 12 mo
double blind
 
apixaban (without LMWH) vs LMWH/VKA
Botticelli DVT ,2008
NCT00252005
apixaban 5 mg twice-daily, 10 mg twice-daily, or 20 mg once-daily for 84-91 days
versus
low molecular weight heparin followed by vitamin K antagonists
patients with symptomatic deep vein thrombosis   Follow-up:
open
 
AMPLIFY ,2013
NCT00643201
apixaban 10 mg twice daily for 7 days then 5 mg, twice daily, 6 months
versus
conventional therapy: enoxaparin 1mg/kg twice daily until INR>=2 then warfarin for an INR between 2-4, once daikly, 6 months
patients with deep vein thrombosis or pulmonary embolism   Follow-up: 6 mo
double blind
 

Atrial fibrillation

These trials are included in meta-analysis concerning: antithrombotics in primary prevention of thromboembolic events, direct factor Xa inhibitors in all type of patients, new oral anticoagulants in all type of patients, antithrombotics in patients ineligible for warfarin,

apixaban vs aspirin
AVERROES ,2011
NCT00496769
apixaban 5 mg (or 2.5 mg) twice daily
versus
aspirin 81-324 md daily
patients with atrial fibrillation who have failed or are unsuitable for vitamin K antagonist treatment  Follow-up: maximum 21 months
double blind
36 countries 
apixaban vs warfarin standard dose
ARISTOTLE ,2011
NCT00412984
apixaban 5mg twice daily
versus
warfarin adjusted for an INR between 2 and 3
subjects with atrial fibrillation and risk factors for stroke   Follow-up: 1.8 yrs (median)
double blind
39 countries 
phase 2 apixaban (unpublished)
NCT00787150
apixaban 5 or 2.5 mg twice daily
versus
warfarin
patient with non valvular AF  Follow-up: 12 weeks
double blind
 

Pulmonary embolism

These trials are included in meta-analysis concerning: antithrombotics in all type of patients,

apixaban 2.5mg vs discontinuation
AMPLIFY-EXT 2.5mg ,2012
NCT00633893
Extended Treatment with apixaban 2.5 mg twice daily 12 months
versus
placebo
patients who have completed their intended treatment for deep vein thrombosis or pulmonary embolism   Follow-up: 12 mo
double blind
 
AMPLIFY-EXT 5mg ,2012
NCT00633893
Extended Treatment with apixaban 5 mg twice daily 12 months
versus
placebo
patients who have completed their intended treatment for deep vein thrombosis or pulmonary embolism   Follow-up: 12 mo
double blind
 
apixaban (without LMWH) vs LMWH/VKA
AMPLIFY ,2013
NCT00643201
apixaban 10 mg twice daily for 7 days then 5 mg, twice daily, 6 months
versus
conventional therapy: enoxaparin 1mg/kg twice daily until INR>=2 then warfarin for an INR between 2-4, once daikly, 6 months
patients with deep vein thrombosis or pulmonary embolism   Follow-up: 6 mo
double blind
 



Entry terms: BMS 562247, apixaban, BMS 562247, BMS562247, BMS-562247




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