Overview

This trial is active, not recruiting.

Conditions stroke, brain ischemia
Treatment acetylsalicylic acid
Sponsor City Clinical Hospital No. 67, Moscow, Russia
Start date August 2016
End date December 2018
Trial size 120 participants
Trial identifier NCT02921360, GKB67-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
Arm
(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
acetylsalicylic acid aspirin
(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

Primary Outcomes

Measure
all cause mortality
time frame: 3 month
ischemic events
time frame: 3 month
haemorrhagic events
time frame: 7 days

Secondary Outcomes

Measure
functional outcome
time frame: 3 month
artery reocclusion
time frame: 7 days

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Randomised Controlled Prospective Trial of Early Administration of Aspirin After Systemic Thrombolysis in Acute Ischemic Stroke
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[1]. 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by City Clinical Hospital No. 67, Moscow, Russia.