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

Conditions: Patients with ischemic strokeMore specific patients with ischemic stroke treated with rt-PA thrombolysis

Registration Number: EUCTR2006-006829-13-NL

Lead Sponsor: etherlands Heart Foundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

?patients with an acute ischemic stroke receiving rt-PA thrombolysis
?age = 18 years
?written informed consent is obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 anticoagulance usage in the previous 5 days
?known legal incompetence of the patient prior to this stroke

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: The secondary objectives are to investigate:<br>?Complications within 48 hours after randomisation like the occurrence of symptomatic intracranial haemorrhage and serious systemic bleeding<br>?Neurological symptoms 7 – 10 days after randomisation or at discharge if the patient is discharged within 7 days<br>?Survival at 3 months<br>?Disability at 3 months<br>?Functional health at 3 months non-dichotomized (ordinal mRS)<br>?Causes of poor outcome;Primary end point(s): Poor functional health defined as dependency or death (mRS 3-6 ) 3 months after randomization is the primary outcome.

Secondary Outcome Measures