| - candidate number | 2330 |
| - NTR Number | NTR822 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 21-nov-2006 |
| - Secondary IDs | N/A |
| - Public Title | Antiplatelet therapy in combination with Recombinant t-PA Thrombolysis in Ischemic Stroke. |
| - Scientific Title | Antiplatelet therapy in combination with Recombinant t-PA Thrombolysis in Ischemic Stroke. |
| - ACRONYM | ARTIS |
| - hypothesis | We hypothesis that antiplatelet therapy adjunctive to rt-PA thrombolysis improves outcome by preventing re-occlusion in terms of three months clinical outcome. |
| - Healt Condition(s) or Problem(s) studied | Ischemic stroke |
| - 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 |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-jul-2008 |
| - planned closingdate | 1-jul-2012 |
| - Target number of participants | 800 |
| - 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. |
| - Primary outcome | 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 outcome | 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. |
| - Timepoints | N/A |
| - Trial web site | www.strokeamc.nl |
| - status | stopped |
| - CONTACT FOR PUBLIC QUERIES | S.M. Zinkstok |
| - CONTACT for SCIENTIFIC QUERIES | S.M. Zinkstok |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Neurology |
| - Funding (Source(s) of Monetary or Material Support) | Netherlands Heart Foundation (NHS, Nederlandse Hartstichting) |
| - Publications | Early administration of aspirin in patients treated with alteplase for acute ischaemic stroke: a randomised controlled trial. Sanne M Zinkstok, Yvo B Roos, on behalf of the ARTIS investigators. www.thelancet.com Published online June 28, 2012 http://dx.doi.org/10.1016/S0140-6736(12)60949-0. |
| - Brief summary | One of the major problems observed in rt-PA thrombolysis in ischemic stroke is the phenomenon of clinical deterioration following initial improvement probably due to reocclusion of the vessel. Acute treatment of ischemic stroke only addresses the degradation of fibrin while a thrombus is formed by both finbrin formation and platelet activation. Reocclusion can be prevented by adding antiplatelet therapy (APT) to rt-PA thrombolysis as has been proven effective in several thrombloysis studies in myocardial infarction. The ARTIS-Trial is a phase III multicenter trial with an Prospective, Randomized, Open treatment, Blind Endpoint (PROBE) design that will enroll 800 patients (400 in each arm). Purpose of the trial is to determine whether adding acute APT to rt-PA thrombolysis in ischemic stroke improves functional outcome at 3 months. Patients with an ischemic stroke eligble for rt-PA thrombolysis are randomised to receive 300mg acetylsalicylic acid intravenously (Asp¨¦gic) within 1.5 hours after the rt-PA bolus or standard care. Primary outcome will be poor functional outcome at 3 months, defined as dependency or death (modified Rankin score 3-6). Among secondary end points are symptomatic intracranial or serious systemic haemorrhages within 48 hours |
| - Main changes (audit trail) | 3-sept-2009: Added: website: www.strokeamc.nl Changed: Blinding from double to single. |
| - RECORD | 21-nov-2006 - 25-mrt-2013 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl