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

Intravenous thrombolysis is the most effective method for the very early treatment of acute cerebral infarction. In order to prevent symptomatic intracranial hemorrhage (SICH), domestic and foreign guidelines recommend starting antiplatelet therapy 24 hours after thrombolysis, but this recommendation is not based on prospective clinical studies. Several studies have shown that 14-34% of recanalization arteries will be re-occluded in a short period of time after thrombolysis. Re-occlusion is mainly caused by platelet accumulation and is closely related to disease deterioration and poor prognosis. On the other hand, the average incidence of SICH is 2.4%, and the proportion of fatal SICH is only 0.28%. Therefore, the impact of re-occlusion on poor prognosis is much greater than that of SICH. This study adopts a prospective randomized controlled open design, and patients with acute cerebral infarction who receive intravenous thrombolysis are randomly divided into two groups: the treatment group starts aspirin 100mg antiplatelet therapy 2 hours after thrombolysis; The control group was given aspirin antiplatelet therapy 24 hours after thrombolysis as usual. The main evaluation indicator was the proportion of good prognosis (mRS score 0\~2 points) at 3 months; the safety evaluation indicators were the incidence of SICH and the case fatality rate of patients at 3 months. Through this study, we intend to evaluate whether early use of aspirin after thrombolysis can improve the prognosis. This study will provide direct clinical evidence for the pros and cons of early initiation of antiplatelet therapy after thrombolysis in patients with cerebral infarction.

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 immediately after the 2-hour post-thrombolysis CT scan (excluding intracranial hemorrhage), followed by aspirin 100mg Qd for 3 months.

Drug: Aspirin

Standard Therapy Group

ACTIVE COMPARATOR

Participants receive oral aspirin 100mg Qd starting at 24 hours post-thrombolysis (after CT confirms no hemorrhage), continuing for 3 months.

Drug: Aspirin

Interventions

Aspirin DRUG

Participants receive oral aspirin 100mg immediately after the 2-hour post-thrombolysis CT scan (excluding intracranial hemorrhage), followed by aspirin 100mg Qd for 3 months.

Early Aspirin Group; 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 4, 2026

Record last verified: 2026-04

Locations

CN (1)