A Phase 2 interventional study of Enoxaparin and Apixaban in Knee Arthroplasty, Total, sponsored by Bayer. Completed at 54 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by Bayer · Phase 2, Interventional, and Prevention
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Among 39 studies in Venous Thromboembolism by Bayer — 1 open to participants now, 2 under way, none of them phase 3. Venous Thromboembolism · Bayer.
Among the 39 studies in Venous Thromboembolism by Bayer, this one is the 9th largest by enrollment of the 16 interventional ones that give a count, is one of 3 that started in 2017, is one of 6 in phase 2, and was the 27th registered.
713 studies on the registry are indexed under Venous Thromboembolism; 147 are open to participants now.
Browse Venous Thromboembolism studies →1 of the 39 studies in Venous Thromboembolism by Bayer is open now, in 4 countries. Recruiting first, the newest first:
Bayer · Sites in Denmark, France, Spain and 1 more country
Ages up to 2
By country, each count listing its studies:
Of the 113 Venous Thromboembolism studies recruiting now, 90 (80%) set no upper age limit and 13 (12%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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39 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 813 is above the median of 241 across 402 interventional studies indexed under Venous Thromboembolism.
Median enrollment 845 across the 16 interventional studies, 3,708 across the 23 observational. Of the 35 that completed or were terminated, 6 (17%) have results posted.
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Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
1 of the studies in Venous Thromboembolism by Bayer that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06765681BayerAn Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related | 2027-04-30 |
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Among the 39 studies in Venous Thromboembolism by Bayer, from their registry updates:
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This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study was open-label, but observer-blinded for the different doses of BAY1213790. This means that it was known which treatment was given, but it was not known which dose of BAY1213790 was administered.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.
Drug: Enoxaparin
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.
Drug: Apixaban
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.
Drug: BAY1213790
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.
Drug: BAY1213790
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.
Drug: BAY1213790
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery.
Drug: BAY1213790
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery.
Drug: BAY1213790
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery.
Drug: BAY1213790
40 mg enoxaparin administered as subcutaneous injection once daily
2.5 mg apixaban administered as tablet orally twice daily
Single dose of BAY1213790 administered as intravenous infusion
Also known as: Osocimab
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.
Time frame: 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.
Time frame: Up to 15 days
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.
Time frame: Up to 157 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.
Time frame: Up to 157 days
Ran from Sep 2017 to primary completion in Aug 2018, 10 months.
Of 27 phase 2 interventional studies under Venous Thromboembolism, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 50. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Osocimab