Trial | NCT02921360  Report issue

Title

Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis
Randomised Controlled Prospective Trial of Early Administration of Aspirin After Systemic Thrombolysis in Acute Ischemic Stroke

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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.
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.
Study Started
Aug 31
2016
Primary Completion
Dec 31
2018
Anticipated
Last Update
Oct 04
2016
Estimate

Drug acetylsalicylic acid

  • Other names: aspirin

12 hours Experimental

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

24 hours No Intervention

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

Criteria 

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
No Results Posted