Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis

Study Overview
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Brief Summary
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The aim of this study is to determine whether early administration of aspirin in acute ischemic stroke patients treated with systemic thrombolysis is safe and can improve outcomes due to decreasing the number of early rethromboses.

Detailed Description
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According to the current guidelines (European Stroke Organisation, 2009; American Heart Association-American Stroke Association, 2013) on the systemic thrombolysis in ischemic stroke patients it is recommended (class C) to start antithrombotic therapy (including antiplatelets and anticoagulants) when 24 hours go after alteplase (rtPA, recombinant tissue plasminogen activator) administration. Meanwhile rtPA has wery short lifetime in blood (T1/2 4-6 minutes). Some retrospective studies have found that early administration of antithrombotics (8-16 hours) after systemic thrombolysis can improve functional outcome and does not increase the risk of haemorrhage. The investigators suggest a controlled prospective trial to recognise risks and benefits of early administration of aspirin (in 12 hours) after rtPA therapy in patients with acute ischemic stroke.

Official Title
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Randomised Controlled Prospective Trial of Early Administration of Aspirin After Systemic Thrombolysis in Acute Ischemic Stroke

Conditions
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Stroke, Brain Ischemia

Intervention / Treatment
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* Drug: acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute ischemic stroke patients treated with rtPA mRS score before current stroke <4 NIHSS score after rtPA treatment <25 Exclusion Criteria: contraindications for treatment with aspirin contraindications fot iodinated radiocontrast agents administration intracranial haemorrhage after rtPA treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 hours<br>Non-contrast CT and CT-angiography are performed in 11 hours after thrombolysis. In case no haematoma is found, patient would receive 100 mg of acetylsalicylic acid per os daily starting from 12 hours after thrombolysis | Drug: acetylsalicylic acid<br> <br> * Other names: aspirin;|
| No Intervention: 24 hours<br>Non-contrast CT and CT-angiography are performed in 23 hours after thrombolysis. In case no haematoma is found, patient would receive 100 mg of acetylsalicylic acid per os daily starting from 24 hours after thrombolysis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 3 month | 
| ischemic events | acute myocardial infarction and ischemic stroke | 3 month | 
| haemorrhagic events | intracerebral haemorrhage, gastrointestinal bleeding, other significant haemorrhage | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome | defined by modified Rankin scale | 3 month | 
| artery reocclusion | verified by CT-angiography | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thrombolytic therapy, tissue plasminogen activator, aspirin