Antiplatelet therapy in combination with Recombinant t-PA Thrombolysis in Ischemic Stroke.

One of the major problems observed in rt-PA thrombolysis in ischemic stroke is the phenomenon of clinical deterioration following initial improvement probably due to reocclusion of the vessel. Acute treatment of ischemic stroke only addresses the degradation of fibrin while a thrombus is formed by both finbrin formation and platelet activation.
Reocclusion can be prevented by adding antiplatelet therapy (APT) to rt-PA thrombolysis as has been proven effective in several thrombloysis studies in myocardial infarction.

The ARTIS-Trial is a phase III multicenter trial with an Prospective, Randomized, Open treatment, Blind Endpoint (PROBE) design that will enroll 800 patients (400 in each arm). Purpose of the trial is to determine whether adding acute APT to rt-PA thrombolysis in ischemic stroke improves functional outcome at 3 months.
Patients with an ischemic stroke eligble for rt-PA thrombolysis are randomised to receive 300mg acetylsalicylic acid intravenously (Asp¨¦gic) within 1.5 hours after the rt-PA bolus or standard care. Primary outcome will be poor functional outcome at 3 months, defined as dependency or death (modified Rankin score 3-6). Among secondary end points are symptomatic intracranial or serious systemic haemorrhages within 48 hours

We hypothesis that antiplatelet therapy adjunctive to rt-PA thrombolysis improves outcome by preventing re-occlusion in terms of three months clinical outcome.

N/A

Patients are randomized to receive either 300 mg acetylsalicylic acid iv (Aspégic) within 1,5 hours after the rt-PA bolus or standard care of rt-PA without Aspégic.