Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02921360
• Other study ID #: GKB67-001
• Status: Active, not recruiting
• Phase: N/A
• First received: September 12, 2016
• Last updated: October 3, 2016
• Start date: August 2016

Study information

• Verified date: October 2016
• Source: City Clinical Hospital No. 67, Moscow, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Ischemia
• Ischemia
• Stroke

Intervention

Drug:
• acetylsalicylic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
City Clinical Hospital No. 67, Moscow, Russia

References & Publications (1)

Amaro S, Llull L, Urra X, Obach V, Cervera Á, Chamorro Á. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		3 month	Yes
Primary	ischemic events	acute myocardial infarction and ischemic stroke	3 month	No
Primary	haemorrhagic events	intracerebral haemorrhage, gastrointestinal bleeding, other significant haemorrhage	7 days	Yes
Secondary	functional outcome	defined by modified Rankin scale	3 month	No
Secondary	artery reocclusion	verified by CT-angiography	7 days	No