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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR822 |
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Date of registration:
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21/11/2006 |
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Primary sponsor: |
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Public title:
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Antiplatelet therapy in combination with Recombinant t-PA Thrombolysis in Ischemic Stroke.
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Scientific title:
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Antiplatelet therapy in combination with Recombinant t-PA Thrombolysis in Ischemic Stroke. - ARTIS |
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Date of first enrolment:
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1/7/2008 |
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Target sample size:
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800 |
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Recruitment status: |
other |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=822 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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S.M.
Zinkstok |
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Address:
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Academic Medical Center
Department of Neurology
Postbus 22660
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5669111 |
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Email:
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s.m.zinkstok@amc.uva.nl |
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Affiliation:
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Name:
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S.M.
Zinkstok |
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Address:
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Academic Medical Center
Department of Neurology
Postbus 22660
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5669111 |
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Email:
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s.m.zinkstok@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Ischemic stroke
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Intervention(s)
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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.
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Primary Outcome(s)
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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 ).
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Netherlands Heart Foundation (NHS, Nederlandse Hartstichting)
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