Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke

Summary

The primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a medium dose of IV rt-PA plus IV eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone.

Timeline

Start

2009-07

Primary completion

2012-10

Completion

2012-12

Outcome

Missed primary endpoint

registry p = 0.053; Odds Ratio (OR) 0.15 (95% CI 0.01 to 1.40); Regression, Logistic NCT00894803 ↗

registry p = 0.23; Odds Ratio (OR) 1.74 (95% CI 0.70 to 4.31); Regression, Logistic NCT00894803 ↗

Publications

• Background Barreto AD, Pedroza C, Grotta JC. Adjunctive medical therapies for acute stroke thrombolysis: is there a CLEAR-ER choice? Stroke. 2013 Sep;44(9):2377-9. doi: 10.1161/STROKEAHA.113.001830. Epub 2013 Jul 25. No abstract available.
• Results Pancioli AM, Adeoye O, Schmit PA, Khoury J, Levine SR, Tomsick TA, Sucharew H, Brooks CE, Crocco TJ, Gutmann L, Hemmen TM, Kasner SE, Kleindorfer D, Knight WA, Martini S, McKinney JS, Meurer WJ, Meyer BC, Schneider A, Scott PA, Starkman S, Warach S, Broderick JP; CLEAR-ER Investigators. Combined approach to lysis utilizing eptifibatide and recombinant tissue plasminogen activator in acute ischemic stroke-enhanced regimen stroke trial. Stroke. 2013 Sep;44(9):2381-7. doi: 10.1161/STROKEAHA.113.001059. Epub 2013 Jul 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eptifibatide	Other / unclassified	0.75 ug/kg	Intravenous
Subject	recombinant tissue plasminogen activator	Protein / enzyme biologic	0.6 mg/kg	Intravenous
Subject	recombinant tissue plasminogen activator	Protein / enzyme biologic	0.9 mg/kg	Intravenous

Indications