Early Low-dose ASpirin Use After Intravenous Thrombolysis for Acute Ischemic Cerebral Infarction（ELASTIC）

Official title

Safety and Efficacy of Treatment With Early Low-dose ASpirin Use After Intravenous Thrombolysis for Acute Ischemic Cerebral Infarction (ELASTIC): A Randomized, Open-label, Blinded Endpoint, Clinical Trial

Overview

This study evaluates whether early administration of low-dose aspirin (100mg) at 2 hours post-intravenous thrombolysis, compared to the standard timing of 24 hours, improves functional outcomes in patients with acute ischemic stroke. Intravenous thrombolysis is effective for very early treatment of acute ischemic stroke. However, current guidelines recommend starting antiplatelet therapy 24 hours after thrombolysis to avoid symptomatic intracranial hemorrhage (SICH), a recommendation not based on prospective clinical studies. Early re-occlusion of recanalized arteries due to platelet aggregation occurs in 14-34% of cases and is associated with poor prognosis. The average incidence of SICH is 2.4%, with fatal SICH occurring in only 0.28%. Thus, the impact of re-occlusion on poor prognosis may outweigh the risk of SICH. In this prospective, randomized, open-label trial with blinded endpoint evaluation, participants are assigned to receive aspirin 100mg either at 2 hours (early group) or at 24 hours (standard group) after thrombolysis. The primary outcome is the proportion of patients with a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-2 at 3 months. Safety outcomes include the incidence of SICH and all-cause mortality at 3 months. This study will provide clinical evidence regarding the optimal timing for initiating antiplatelet therapy after thrombolysis in acute ischemic stroke.

Interventions

• Drug Aspirin (Early, 2h)
  Aspirin 100mg orally, administered once daily. The first dose is given at 2 hours after rt-PA thrombolysis, conditional on a follow-up CT scan at 2 hours excluding intracranial hemorrhage. Treatment continues for 3 months.
• Drug Aspirin (Standard, 24h)
  Aspirin 100mg orally, administered once daily. The first dose is given at 24 hours after rt-PA thrombolysis, conditional on a follow-up CT scan at 24 hours confirming no intracranial hemorrhage. Treatment continues for 3 months.

Primary outcome measures

• Proportion of Patients with Favorable Functional Outcome at 3 Months [Time frame: 3 months]

Secondary outcome measures (2)

• Incidence of symptomatic intracranial hemorrhage [Time frame: 24 hour]
• Patient mortality rate at 3 months [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• Age range: 18-65 years old
• Receive rt PA thrombolytic therapy within 3 hours (including 3 hours) of onset
• Signs of brain dysfunction lasting for more than 1 hour
• CT imaging excludes cerebral hemorrhage, and there are no imaging changes corresponding to the patient's physical signs

Exclusion criteria

• Age>65 years old
• Onset time>3 hours
• Accompanied by consciousness disorders, or NIHSS ≥ 20 points
• CT shows' high-density shadow of middle cerebral artery '
• Accompanied by atrial fibrillation or clearly identified as cardioembolic embolism
• Severe swallowing difficulties, unable to take medication orally
• Oral anticoagulant medication is currently being taken
• Accompanied by severe infection or evidence of severe infection
• Refusal to sign the informed consent form for this study
• Exclusion criteria for other traditional intravenous thrombolysis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijng Chao-Yang Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07563673 · Beijing CYH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗