Antiplatelet therapy in combination with Recombinant t-PA Thrombolysis in Ischemic Stroke.
Suspended
- Conditions
- Re-occlussion in ischemic stroke.
- Registration Number
- NL-OMON24653
- Lead Sponsor
- etherlands Heart Foundation (Nederlandse Hartstichting).
- Brief Summary
Early administration of aspirin in patients treated with alteplase for acute ischaemic stroke: a randomised controlled trial.<br> Sanne M Zinkstok, Yvo B Roos, on behalf of the ARTIS investigators.<br> www.thelancet.com Published online June 28, 2012 http://dx.doi.org/10.1016/S0140-6736(12)60949-0.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
1. Patients with an acute ischemic stroke receiving rt-PA thrombolysis
2. Age ≥ 18 years
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 ). <br>
- Secondary Outcome Measures
Name Time Method The secondary objectives are to investigate complications within 48 hours after randomisation like:<br /><br>- the occurrence of symptomatic intracranial haemorrhage and serious systemic bleeding; <br /><br>- neurological symptoms 7 – 10 days after randomisation or at discharge if the patient is discharged within 7 days;<br /><br>- survival at 3 months;<br /><br>- disability at 3 months;<br /><br>- functional health at 3 months non-dichotomized (ordinal mRS);<br /><br>- causes of poor outcome.<br /><br><br>