Cerebral InfarctionPhase 4ELASTICNCT07563673
Early Low-dose ASpirin Use After Intravenous Thrombolysis for Acute Ischemic Cerebral Infarction（ELASTIC）
A Phase 4 study testing Aspirin (Early, 2h) and Aspirin (Standard, 24h) in people with Cerebral Infarction and Thrombolysis, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Infarction, Thrombolysis
- What is being tested?
- Aspirin (Early, 2h) and Aspirin (Standard, 24h)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijng Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
About this study
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
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
- Being tested
- Aspirin (Early, 2h), Aspirin (Standard, 24h)
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Aspirin (Standard, 24h) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
Incidence of symptomatic intracranial hemorrhage
Measured: 24 hour
Patient mortality rate at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563673
- Sponsor's protocol ID
- Beijing CYH
- Acronym
- ELASTIC
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07563673
- Acronym / sponsor ID
- ELASTIC / Beijing CYH
- Conditions
- Cerebral Infarction, Thrombolysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Aspirin Group | Experimental | Drug: Aspirin (Early, 2h)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. |
| Standard Therapy Group | Active comparator | Drug: Aspirin (Standard, 24h)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Early Aspirin Group |
| 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. | Drug | Standard Therapy Group |
Primary outcome
Proportion of Patients with Favorable Functional Outcome at 3 Months
Time frame: 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.
2 secondary outcomes
Incidence of symptomatic intracranial hemorrhage
Time frame: 24 hour
Patient mortality rate at 3 months
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin (Early, 2h) and Aspirin (Standard, 24h) in people with Cerebral Infarction and Thrombolysis, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Lu, MD (010-8523-1391, brian0317@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients with Favorable Functional Outcome at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.