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

NCT07563673 | Not Yet Recruiting Phase 4

• 1 other identifier: Beijing CYH
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Infarction; Thrombolysis

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients with Favorable Functional Outcome at 3 Months

  Favorable functional outcome is defined as a score of 0 to 2 on the modified Rankin Scale (mRS). The mRS score will be assessed by a blinded endpoint assessor at 3 months post-stroke via a structured telephone interview or during a clinic visit.

  3 months

Secondary Outcomes (2)

• Incidence of symptomatic intracranial hemorrhage

  24 hour

• Patient mortality rate at 3 months

  3 months

Study Arms (2)

Early Aspirin Group

EXPERIMENTAL

Participants receive oral aspirin 100mg at 2 hours after rt-PA thrombolysis. A follow-up CT scan is performed at 2 hours post-thrombolysis. If no intracranial hemorrhage is confirmed, aspirin 100mg once daily (Qd) is continued for 3 months.

Drug: Aspirin (Early, 2h)

Standard Therapy Group

ACTIVE COMPARATOR

Participants receive oral aspirin 100mg once daily (Qd) starting at 24 hours after rt-PA thrombolysis. A follow-up CT scan is performed at 24 hours post-thrombolysis. If no intracranial hemorrhage is confirmed, aspirin 100mg once daily (Qd) is continued for 3 months.

Drug: Aspirin (Standard, 24h)

Interventions

Aspirin (Early, 2h) DRUG

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.

Early Aspirin Group

Aspirin (Standard, 24h) DRUG

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.

Standard Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijng Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Ming Lu, MD

CONTACT

010-8523-1391; brian0317@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

CN (1)