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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetylsalicylic acid | Drug |
|
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| functional outcome | defined by modified Rankin scale | 3 month |
| artery reocclusion | verified by CT-angiography | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23951093 | Background | Amaro S, Llull L, Urra X, Obach V, Cervera A, Chamorro A. Risks and benefits of early antithrombotic therapy after thrombolytic treatment in patients with acute stroke. PLoS One. 2013 Aug 8;8(8):e71132. doi: 10.1371/journal.pone.0071132. eCollection 2013. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |