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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

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.

Condition or disease Intervention/treatment Phase
Stroke Brain Ischemia Drug: acetylsalicylic acid Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomised Controlled Prospective Trial of Early Administration of Aspirin After Systemic Thrombolysis in Acute Ischemic Stroke
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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
Drug: acetylsalicylic acid
Other Name: aspirin

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



Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 3 month ]
  2. ischemic events [ Time Frame: 3 month ]
    acute myocardial infarction and ischemic stroke

  3. haemorrhagic events [ Time Frame: 7 days ]
    intracerebral haemorrhage, gastrointestinal bleeding, other significant haemorrhage


Secondary Outcome Measures :
  1. functional outcome [ Time Frame: 3 month ]
    defined by modified Rankin scale

  2. artery reocclusion [ Time Frame: 7 days ]
    verified by CT-angiography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications:
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Responsible Party: City Clinical Hospital No. 67, Moscow, Russia
ClinicalTrials.gov Identifier: NCT02921360     History of Changes
Other Study ID Numbers: GKB67-001
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Keywords provided by City Clinical Hospital No. 67, Moscow, Russia:
thrombolytic therapy
tissue plasminogen activator
aspirin
Additional relevant MeSH terms:
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Stroke
Brain Ischemia
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics