The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke - Enhanced Regimen (CLEAR-ER) is an NIH funded, multicenter, randomized, double-blind trial to determine the safety of the combination of medium dose rt-PA (0.6 mg/kg total) plus eptifibatide (bolus 135 mcg/kg and 2 hour infusion at 0.75 mcg/kg/min) compared to standard dose rt-PA (0.9 mg/kg) in patients with acute ischemic stroke that can have the rt-PA initiated within 3 hours of symptom onset.
The primary safety outcome measure will be symptomatic ICH within 36 hours of initiation of therapy. The primary efficacy outcome measure is the modified Rankin Scale score ≤1 or return to mRS baseline at 90 days.
To be eligible, patients must have an acute ischemic stroke and must have treatment initiated within 3 hours of symptom onset. Additionally patients must be 18-85 years of age and have an NIH Stroke Scale >5. In total, 126 patients from 9 centers are projected to be randomized in this trial.
Overall, the CLEAR-ER trial will: