• PI: Opeolu M. Adeoye MD
  • Sponsor: NIH/NINDS
  • Study #: 2P50NS044283-06
User Name

Password

Welcome

The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke – Full Dose Regimen (CLEAR-FDR) is an NIH funded, single-arm, prospective, open- label, multi-site study to determine the safety of the combination of rt-PA (0.9 mg/kg) plus eptifibatide (bolus 135 mcg/kg and 2 hour infusion at 0.75 mcg/kg/min) in patients with acute ischemic stroke that can have the rt-PA initiated within 3 hours of symptom onset. Time of onset is defined as the last time the patient was witnessed to be at baseline.

The primary outcome variable is the proportion of patients who experience sICH as defined in the NINDS stroke trial. Secondary outcomes include: the presence of any ICH and the proportion of patients who develop parenchymal hemorrhage types 1 (PH-1) and 2 (PH-2); and, 90 day outcomes as measured by the modified Rankin score.

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, 30 patients from 8 hospitals are projected to be enrolled in this trial.

Overall, the CLEAR-FDR trial will:

CLEAR-FDR TRIAL 24-hour EMERGENCY HOTLINE: 1-513-844-7686

Participating Centers: