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

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ClinicalTrials.gov Identifier: NCT02921360
Recruitment Status : Unknown
Verified October 2016 by City Clinical Hospital No. 67, Moscow, Russia.
Recruitment status was:  Active, not recruiting
First Posted : October 3, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
City Clinical Hospital No. 67, Moscow, Russia

Tracking Information
First Submitted Date  ICMJE September 12, 2016
First Posted Date  ICMJE October 3, 2016
Last Update Posted Date October 4, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • all cause mortality [ Time Frame: 3 month ]
  • ischemic events [ Time Frame: 3 month ]
    acute myocardial infarction and ischemic stroke
  • haemorrhagic events [ Time Frame: 7 days ]
    intracerebral haemorrhage, gastrointestinal bleeding, other significant haemorrhage
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02921360 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • functional outcome [ Time Frame: 3 month ]
    defined by modified Rankin scale
  • artery reocclusion [ Time Frame: 7 days ]
    verified by CT-angiography
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Administration of Aspirin in Patients With Acute Ischemic Stroke Treated With Systemic Thrombolysis
Official Title  ICMJE Randomised Controlled Prospective Trial of Early Administration of Aspirin After Systemic Thrombolysis in Acute Ischemic Stroke
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Stroke
  • Brain Ischemia
Intervention  ICMJE Drug: acetylsalicylic acid
Other Name: aspirin
Study Arms  ICMJE
  • Experimental: 12 hours
    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
    Intervention: Drug: acetylsalicylic acid
  • No Intervention: 24 hours
    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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 29, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02921360
Other Study ID Numbers  ICMJE GKB67-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City Clinical Hospital No. 67, Moscow, Russia
Study Sponsor  ICMJE City Clinical Hospital No. 67, Moscow, Russia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account City Clinical Hospital No. 67, Moscow, Russia
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP