POst-Therapy ENhanced Thrombocyte Inhibition At Low NIHSS score (POTENTIAL) – A randomized controlled multicenter trial

Condition studied

Secondary prevention after stroke

Investigational medicinal product(s)

Every trial of Clopidogrel across our registers →

Eligibility

Primary endpoint

Recurrent ischemic stroke, defined as at least one new ischemic lesion on cMRI on day 25 ± 4 compared to baseline cMRI

Endpoint detail

­Imaging-confirmed symptomatic recurrent AIS by day 25 ± 4, ­ Imaging-confirmed silent recurrent AIS by day 25 ± 4, ­ Volume of new ischemic lesions on follow-up MRI on day 25 ± 4, ­ Symptomatic myocardial infarction by day 25 ± 4 and by day 90 ± 7, ­ Death from ischemic vascular cause by day 90 ± 7, ­ All-cause mortality by day 90 ± 7, ­ Change in NIHSS on day 25 ± 4 compared to day 1, ­ MoCA on day 25 ± 4 and change compared to day 1, ­ mRS on day 90 ± 7, ­ Major bleedings (composite endpoint defined as (1) fatal bleeding, (2) symptomatic bleeding in a critical area or organ (e.g.: intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, intramuscular with compartment syndrome), (3) bleeding with a drop in hemoglobin of ≥ 2 g/dL (1.24 mmol/L), (4) bleeding with transfusion of ≥ 2 units of whole blood or packed red blood cells) by day 90 ± 7, ­ Minor bleedings by day 90 ± 7, ­ Clinically relevant non-major bleedings (CRNM) by day 90 ± 7, ­ Bleeding of any kind detected on follow-up MRI on day 25 ± 4, ­ Clinically silent intracranial bleeding on follow-up MRI on day 25 ± 4, ­ Number of newly occurring microbleeds measured by susceptibility-weighted imaging (SWI) on day 25 ± 4, ­ Number and type of AEs and SAEs