Re-occlussion in ischemic stroke.
Conditions
Interventions
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.
Sponsors
Netherlands Heart Foundation (Nederlandse Hartstichting).
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with an acute ischemic stroke receiving rt-PA thrombolysis 2. Age ≥ 18 years 3. Written informed consent is obtained
Exclusion criteria
Exclusion criteria: 1. Known APT in the previous 5 days(in case of uncertainty the patient may be included) 2. Known thrombocytopenia (thrombocyte count ≥ 100 * 10E9/l) 3. Known contra-indications to ASA treatment (e.g. previous adverse reaction to ASA) 4. Known anticoagulance usage in the previous 5 days 5. Known legal incompetence of the patient prior to this stroke
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the ARTIS-Trial is to investigate whether the addition of acute APT to standard rt-PA thrombolysis reduces poor outcome 3 months after an acute ischemic stroke. Poor outcome is defined as death or dependency (mRS 3-6 ). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 – 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. | — |
Contacts
Public ContactS.M. Zinkstok
Academic Medical Center Department of Neurology Postbus 22660
Outcome results
None listed