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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02921360

Enrollment

120

Registered

2016-10-03

Start date

2016-08-31

Completion date

Unknown

Last updated

2016-10-04

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

Conditions

Brain Ischemia, Stroke

Keywords

thrombolytic therapy, tissue plasminogen activator, aspirin

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.

Interventions

DRUGacetylsalicylic acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026