FactOr XIa inhibiTion for the pRevention of venOus Thromb... | NCT03276143

ID	Type	Description	Link
2016-002681-31	EudraCT Number

Official Title

A Randomized, Active-comparator-controlled, Multicenter Study to Assess the Safety and Efficacy of Different Doses of BAY1213790 for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Primary Total Knee Arthroplasty, Open-label to Treatment and Observer-blinded to BAY1213790 Doses

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enoxaparin	Active Comparator	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.	Drug: Enoxaparin
Apixaban	Active Comparator	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.	Drug: Apixaban
BAY1213790 0.3 mg/kg (post-surgery)	Experimental	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.	Drug: BAY1213790
BAY1213790 0.6 mg/kg (post-surgery)	Experimental	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.	Drug: BAY1213790
BAY1213790 1.2 mg/kg (post-surgery)	Experimental	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.	Drug: BAY1213790

Name	Type	Description	Arm Group Labels	Other Names
Enoxaparin	Drug	40 mg enoxaparin administered as subcutaneous injection once daily	Enoxaparin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded	DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.	Up to 15 days
Incidence of composite endpoint of major and clinically relevant non-major bleeding	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.	Up to 15 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence of composite endpoint of symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Day 157 or objectively confirmed asymptomatic DVT up to Day 15	All suspected events were reviewed and classified by the Central Independent Adjudication Committee.	Up to 157 days

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UMHAT Sveti Georgi		Plovdiv		4002	Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatm

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31935028	Derived	Weitz JI, Bauersachs R, Becker B, Berkowitz SD, Freitas MCS, Lassen MR, Metzig C, Raskob GE. Effect of Osocimab in Preventing Venous Thromboembolism Among Patients Undergoing Knee Arthroplasty: The FOXTROT Randomized Clinical Trial. JAMA. 2020 Jan 14;323(2):130-139. doi: 10.1001/jama.2019.20687.

ID	Term
D054556	Venous Thromboembolism
D020246	Venous Thrombosis

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013927	Thrombosis

ID	Term
D017984	Enoxaparin
C522181	apixaban
C000657125	osocimab

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates