To investigate whether standard rt-PA thrombolysis in combination with antiplatelet therapy in acute ischemic stroke is beneficial in clinical outcomes following stroke, and in preventing re-occlusion.
- Tissue plasminogen activator (Activase®)Drug
Other Names: Alteplase; tPA Intervention Desc: Thrombolytic
- Aspirin Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
Prospective, Randomized, Open treatment, Blind Endpoint (PROBE) design
Patients are randomized to receive either 300 mg acetylsalicylic acid iv (Aspegic) within 1.5 hours after the bolus rt-PA or rt-PA or standard care without Aspegic.
|Type||Measure||Time Frame||Safety Issue|
|Primary||The primary objective of the ARTIS-Trial is to investigate whether acute APT Whether the addition to standard rt-PA thrombolysis Reduces poor outcome 3 months after an acute ischemic stroke. Poor outcome was defined as death or dependency (MRS 3-6).|
|Secondary||The secondary objectives are to investigate complications within 48 hours after randomisation like: - The occurrence of symptomatic intracranial haemorrhage and serious systemic bleeding; - Neurological symptoms 7 to 10 days after randomisation or at discharge if the patient is discharged within 7 days; - Survival at 3 months; - Disability at 3 months; - Functional health at 3 months non-dichotomized (ordinal MRS); - Causes of poor outcome.|