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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31665
Enrollment
800
Registered
2008-01-21
Start date
2008-02-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic stroke

Interventions

Patients are randomized to receive either 300 mg acetylsalicyclicacid iv (Aspégic) within 1,5 hours after the rt-PA bolus or standard care of rt-PA without Aspégic.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * patients with an acute ischemic stroke receiving rt-PA thrombolysis * age * 18 years * written informed consent is obtained

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary endpoint is poor functional health at 3 months defined as dependency or death (mRS 3 * 6).

Secondary

MeasureTime frame
Secondary outcomes are symptomatic intracranial or serious systemic haemorrhages within 48 hours, neurological symptoms at 7 * 10 days and survival, disability assessed with the ALDS scale, functional health on the full ordinal range of the modified Rankin Scale at 3 months and the causes of poor outcome.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)