Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis
- Registration Number
- NCT02921360
- Lead Sponsor
- City Clinical Hospital No. 67, Moscow, Russia
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- acute ischemic stroke patients treated with rtPA
- mRS score before current stroke <4
- NIHSS score after rtPA treatment <25
- contraindications for treatment with aspirin
- contraindications fot iodinated radiocontrast agents administration
- intracranial haemorrhage after rtPA treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 12 hours acetylsalicylic acid 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
- Primary Outcome Measures
Name Time Method all cause mortality 3 month ischemic events 3 month acute myocardial infarction and ischemic stroke
haemorrhagic events 7 days intracerebral haemorrhage, gastrointestinal bleeding, other significant haemorrhage
- Secondary Outcome Measures
Name Time Method functional outcome 3 month defined by modified Rankin scale
artery reocclusion 7 days verified by CT-angiography