Conducted over the course of eight years at 69 medical centers in the U.S. and Canada, the RESPECT study followed 980 participants who had suffered a cryptogenic stroke that was confirmed by stroke neurologists using routine imaging technologies. The average age of the patients in this trial was 46-years old. The trial was a prospective, controlled, randomized (1:1) study in which patients were randomly assigned to either the device group or the medical group. The primary efficacy endpoint was defined as the composite rate of recurrent nonfatal stroke, fatal ischemic stroke or death after randomization. Enrollment was stopped once 25 events occurred, all of which were non-fatal recurrent stroke, as measured across all patients in the study.Patients in the device group underwent a procedure in which their PFO was closed with the Amplatzer PFO Occluder followed by six months of medication therapy. In the medical group, four standard-of-care medical therapy regimens were used throughout the study: aspirin, warfarin, clopidogrel and aspirin combined with extended release dipyridamole.
- Per-protocol cohort – patients who received the randomly assigned treatment and adhered to the protocol-mandated medical treatment
- As-treated cohort – patients who received and adhered to a protocol-approved treatment and were classified according to the treatment they actually received