Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial


Phase 1/2 Results


The study enrolled a total of 94 subjects; 40 in dose tier 1 and 54 in dose tier 2. The combination cohort had a total of 69 patients with a median age of 71, and a median baseline NIHSS of 14. The standard dose rt-PA group had 25 patients with a median age of 61 and a median baseline NIHSSS of 10 (p=0.01 for NIHSSS). There was 1 (1.4%) symptomatic ICH in the combination group and 2 (8.0%) in the standard treatment arem (p=0.17). There was a non-significant trend toward increased efficacy with the standard dose rt-PA treatment arm. The adjusted odds ratio and associated 95% confidence intervals for achieving a good outcome in the experimental group as compared to the control group: 90-day mRS of 0-1 or return to baseline OR=0.53 (0.19, 1.53). 90-day GOS of zero OR=0.95 (0.34, 2.68). (Adjusted for age, baseline NIHSSS, baseline Rankin, time to treatment, history of diabetes and age by NIHSSS interaction). The combination of eptifibatide and reduced dose rt-PA is safe enough for consideration of further dose ranging trials in acute ischemic stroke.