Synapse
⌘+K
Synapse
PulseExploreClubsResearchersJournals
Instagram
HomeClubsExplore
January 1, 2010Thrombosis and Haemostasis

A dose-finding study with TAK-442, an oral factor Xa inhibitor, in patients undergoing elective total knee replacement surgery

View Full Paper
Ask AI
Bookmark
Share

Why the study?

Does TAK-442 prevent deep-vein thrombosis, pulmonary embolism, or mortality compared to enoxaparin in patients undergoing elective total knee replacement surgery?

Population

1,038 patients undergoing elective total knee replacement surgery

Comparison

Oral TAK-442 started 6-8 hours postoperatively… vs Open-label subcutaneous enoxaparin 30 mg…

Design

RCT, randomised, TAK-442 blinded as to dose, enoxaparin open-label

Follow-up

maximum of 14 days

Authors

CCCharlie CaoBiogen (United States)BEBengt I. ErikssonKarolinska InstitutetSKStuart KupferUniversity of North Carolina at Chapel Hill

Discussion

Loading...

Member takes

Implication

TAK-442 at 40-80 mg doses offers similar thromboprophylaxis to enoxaparin after knee arthroplasty; extends oral factor Xa inhibitor options in orthopedic surgery.

Structured PICO

Does TAK-442 prevent deep-vein thrombosis, pulmonary embolism, or mortality compared to enoxaparin in patients undergoing elective total knee replacement surgery?

P
Population
1,038 patients undergoing elective total knee replacement surgery
I
Intervention
Oral TAK-442 (40 or 80 mg once-daily or 10, 20, 40, or 80 mg twice-daily) started 6-8 hours postoperatively for 10 days (maximum 14 days)
C
Comparator
Open-label subcutaneous enoxaparin 30 mg twice-daily starting 12-24 hours postoperatively for 10 days
O
Outcome
Composite of any deep-vein thrombosis, non-fatal pulmonary embolism or all-cause mortalitycomposite

TAK-442 at doses of 40 mg QD, 40 mg BID, 80 mg QD, and 80 mg BID showed similar efficacy and safety to enoxaparin for thromboprophylaxis after knee arthroplasty, while lower doses (10 and 20 mg BID) were less effective.

Cite This Study

Cao et al. (2010) studied this question.

synapsesocial.com/papers/6a8fbc61e75f31f587cedd6fhttps://doi.org/10.1160/th10-05-0273

Topics

Pulmonary embolism
View Full Paper
Ask AI
Bookmark
Share

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Phase II Dose-Finding Study with TAK-442, An Oral Factor Xa Inhibitor, in Patients Undergoing Elective Knee Arthroplasty.2009 · 8 citations
  2. 2An Adaptive-Design Dose-Ranging Study of PD 0348292, a New Oral Factor Xa Inhibitor, for Thromboprophylaxis after Total Knee Replacement Surgery.2008 · 13 citations
  3. 3Edoxaban in Patients Undergoing Total Hip Arthroplasty: A Phase IIb Dose-Finding Study.2009 · 15 citations
  4. 4A Phase II Randomized, Double-Blind, Eight-Arm, Parallel-Group, Dose-Response Study of Apixaban, a New Oral Factor Xa Inhibitor for the Prevention of Deep Vein Thrombosis in Knee Replacement Surgery - On Behalf of the Apixaban Investigators.2006 · 27 citations
  5. 5Safety and Efficacy of Edoxaban, an Oral Factor Xa Inhibitor, for Thromboprophylaxis After Total Hip Arthroplasty in Japan and Taiwan2014 · 57 citations