A Phase 2 interventional study of MAA868 and Apixaban in Atrial Fibrillation, sponsored by Novartis Pharmaceuticals. Withdrawn. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Basic science
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
Browse Atrial Fibrillation studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
patients receive dose monthly.
Drug: MAA868
patients receive dose monthly.
Drug: MAA868
patients receive dose monthly.
Drug: MAA868
Apixaban 5 mg b.i.d
Drug: Apixaban
number of patients achieving FXI inhibition ≥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition
Occurrence of achieving ≥ 80% inhibition of FXI (\< 20% free FXI) following 3 months of treatment.
Time frame: month 3
number of patients achieving FXI inhibition ≥ 80% at trough after the first and second dose at 3 dose levels of MAA868
Occurrence of achieving ≥ 80% inhibition of FXI (\< 20% free FXI) at trough on Month 1 and Month 2
Time frame: Month 1 and 2
Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period.
Incidence of major or clinically relevant non-major bleeding events
Time frame: day 1 to day 91
the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator
Change from baseline to Day 31, Day 61 and Day 91 in thrombogenesis biomarkers (D-dimer, prothrombin fragment 1.2 (F1.2), thrombin-antithrombin III-complexes (TAT), fibrinogen).
Time frame: Days 31, 61 and 91
No study locations are listed for this record.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
No publications or documents are linked to this record.
Start is estimated for Oct 2018; primary completion for Nov 2019, 13 months later.
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This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Abelacimab