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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Interventions

  • Tissue plasminogen activator (Activase┬«)Drug
    Other Names: Alteplase; tPA
    Intervention Desc: Thrombolytic
  • Aspirin Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic

Trial Design

Prospective, Randomized, Open treatment, Blind Endpoint (PROBE) design

Patient Involvement

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.

Outcomes

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.

Sponsors

Academic Medical Center (AMC), Department of Neurology