Antiplatelet therapy in combination with Recombinant t-PA Thrombolysis in Ischemic Stroke
Phase 3
- Conditions
- ischemic stroke1000796310014523
- Registration Number
- NL-OMON31665
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
* patients with an acute ischemic stroke receiving rt-PA thrombolysis
* age * 18 years
* written informed consent is obtained
Exclusion Criteria
* known APT in the previous 5 days(in case of uncertainty the patient may be included)
* known thrombocytopenia (thrombocyte count * 100 * 10E9/l)
* known contra-indications to ASA treatment (e.g. previous adverse reaction to ASA)
* Known anticoagulans usage in the previous 5 days
* known legal incompetence of the patient prior to this stroke
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is poor functional health at 3 months defined as<br /><br>dependency or death (mRS 3 * 6). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are symptomatic intracranial or serious systemic<br /><br>haemorrhages within 48 hours, neurological symptoms at 7 * 10 days and<br /><br>survival, disability assessed with the ALDS scale, functional health on the<br /><br>full ordinal range of the modified Rankin Scale at 3 months and the causes of<br /><br>poor outcome.</p><br>