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
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedOctober 4, 2016
October 1, 2016
2.3 years
September 12, 2016
October 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
all cause mortality
3 month
ischemic events
acute myocardial infarction and ischemic stroke
3 month
haemorrhagic events
intracerebral haemorrhage, gastrointestinal bleeding, other significant haemorrhage
7 days
Secondary Outcomes (2)
functional outcome
3 month
artery reocclusion
7 days
Study Arms (2)
12 hours
EXPERIMENTALNon-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
24 hours
NO INTERVENTIONNon-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
Interventions
Eligibility Criteria
You may qualify if:
- acute ischemic stroke patients treated with rtPA
- mRS score before current stroke \<4
- NIHSS score after rtPA treatment \<25
You may not qualify if:
- contraindications for treatment with aspirin
- contraindications fot iodinated radiocontrast agents administration
- intracranial haemorrhage after rtPA treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Amaro S, Llull L, Urra X, Obach V, Cervera A, Chamorro A. 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.
PMID: 23951093BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2016
First Posted
October 3, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2018
Last Updated
October 4, 2016
Record last verified: 2016-10