Another big trial, the NOAH – AFNET 6 study, sponsored by the non-profit research network AFNET e.V. has started. By the end of June the first patient has been included. In total 3400 patients will be enrolled into this international phase IIIb study in about 230 sites in 15 European countries.
The main purpose of the NOAH - AFNET 6 study is to demonstrate that oral anticoagulation with the NOAC edoxaban is superior to current therapy (antiplatelet therapy or no therapy depending on cardiovascular risk) to prevent stroke, systemic embolism, or cardiovascular death in patients with atrial high rate episodes (=AHRE) but without atrial fibrillation and at least two stroke risk factors.
CRI is the full service lead CRO for this project and will provide all necessary services ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes also all regulatory issues, handling of contracts, data management services as well as monitoring, safety and site reimbursement.