Ischemic StrokePhase 4NCT05193071

Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

A Phase 4 study testing Aspirin 100mg; Clopidogrel 300mg in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The current guideline recommends to give antithrombotic treatment 24 hours after intravenous thrombolysis in acute ischemic stroke. However, early neurological deterioration will occur in some patients due to no antithrombotic treatment, which is closely associated with poor outcome. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Stroke
What is being tested?: Aspirin 100mg; Clopidogrel 300mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,022 participants
Where: 2 sitesChina
Study dates: 8 Jul 2022to 25 Oct 2024
Phase: Phase 4
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years old;
Acute ischemic stroke patients who received intravenous thrombolysis within 4.5 hours of onset;
NIHSS ≤ 5 within 6 hours after the end of intravenous thrombolysis, and no bleeding transformation was found in head CT examination;
Premorbid mRS ≤ 1;
Signed informed consent.

Who cannot join

Premorbid mRS≥2;
Uncontrolled severe hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg after drug treatment);
Antithrombotic treatment within 24 hours before randomization;
Significant dysphagia and inability to take the experimental drug orally;
Allergy or contraindication to study drugs;
Comorbidity with any serious diseases and life expectancy is less than half a year;
Participating in other clinical trials within three months;
Patients not suitable for this clinical study considered by researcher

Trial locations and contacts

2 sites in 1 country.

China2 sites

Hui-sheng Chen
Shenyang, None Selected, 110840
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016

Other trials in China

About this study

Official title: Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST): a Prospective, Random, Double Blinded and Multi-center Study

Conditions: Ischemic Stroke
Being tested: Aspirin 100mg; Clopidogrel 300mg
Keywords: thrombolysis, minor stroke, early antiplatelet
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aspirin 100mg; Clopidogrel 300mgDrug
Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization

Study groups in NCT05193071
Study group	Role	What they receive
double antiplatelet group	Experimental	aspirin 100mg plus clopidogrel 300mg Receives: Drug: Aspirin 100mg; Clopidogrel 300mg
control group	Placebo comparator	aspirin placebo plus clopidogrel placebo Receives: Drug: Aspirin 100mg; Clopidogrel 300mg

What is being measured

The primary outcome is the main question the study is designed to answer.

The proportion of excellent prognosis
excellent prognosis is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Measured: Day 90

Secondary outcomes (8)

The proportion of favorable prognosis
Favorable prognosis is defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome.
Measured: Day 90
Distribution of modified Rankin Score (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome.
Measured: Day 90
Changes in National Institute of Health stroke scale (NIHSS)
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Measured: 24 hours, 48 hours, and 10 days
Occurrence of early neurologyical deterioration (END)
END is defined as more than 2 point increase, but not result of cerebral hemorrhage, compared with baseline at 24 hours
Measured: 24 hours
The incidence of symptomatic intracerebral hemorrhage
any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
Measured: 36 hours
The incidence of any intracerebral hemorrhage
the evidence of bleeding on the head CT or MRI scan
Measured: 36 hours
The incidence of stroke recurrence and other vascular events
Measured: Day 90
The death due to any cause
Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 202225 Oct 2024

First posted14 Jan 2022
Study start8 Jul 2022
Primary completion25 Oct 2024
Study completion25 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,022 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05193071
Sponsor's protocol ID: y (2021) 109
Status last verified: Oct 2024
First submitted: 31 Dec 2021
Last updated: 31 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Cui Y, Liu JL, Jiang CH, Hou XW, Chen HS. Diabetes Mellitus and Early Antiplatelet Treatment for Minor Stroke Following Intravenous Thrombolysis: Prespecified Secondary Analysis of the EAST Trial. Diabetes Obes Metab. 2026 Jul;28(7):5604-5613. doi: 10.1111/dom.70745. Epub 2026 Apr 7.
PubMed 41944218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST): a Prospective, Random, Double Blinded and Multi-center Study
ClinicalTrials.gov ID: NCT05193071
Acronym / sponsor ID: y (2021) 109
Conditions: Ischemic Stroke
Keywords: thrombolysis, minor stroke, early antiplatelet
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,022 participants (actual)
Lead sponsor: General Hospital of Shenyang Military RegionUniversity, hospital or other
Study start: 8 Jul 2022 (actual)
Primary completion: 25 Oct 2024 (actual)
Study completion: 25 Oct 2024 (actual)
First posted: 14 Jan 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
double antiplatelet group	Experimental	Drug: Aspirin 100mg; Clopidogrel 300mgaspirin 100mg plus clopidogrel 300mg
control group	Placebo comparator	Drug: Aspirin 100mg; Clopidogrel 300mgaspirin placebo plus clopidogrel placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥ 18 years old;
Acute ischemic stroke patients who received intravenous thrombolysis within 4.5 hours of onset;
NIHSS ≤ 5 within 6 hours after the end of intravenous thrombolysis, and no bleeding transformation was found in head CT examination;
Premorbid mRS ≤ 1;
Signed informed consent.

Key exclusion criteria (8 listed)

Premorbid mRS≥2;
Uncontrolled severe hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg after drug treatment);
Antithrombotic treatment within 24 hours before randomization;
Significant dysphagia and inability to take the experimental drug orally;
Allergy or contraindication to study drugs;

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 100mg; Clopidogrel 300mgAspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization	Drug	control group, double antiplatelet group

Primary outcome

The proportion of excellent prognosis
Time frame: Day 90
excellent prognosis is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

8 secondary outcomes

The proportion of favorable prognosis
Time frame: Day 90
Distribution of modified Rankin Score (mRS)
Time frame: Day 90
Changes in National Institute of Health stroke scale (NIHSS)
Time frame: 24 hours, 48 hours, and 10 days
Occurrence of early neurologyical deterioration (END)
Time frame: 24 hours
The incidence of symptomatic intracerebral hemorrhage
Time frame: 36 hours
The incidence of any intracerebral hemorrhage
Time frame: 36 hours
The incidence of stroke recurrence and other vascular events
Time frame: Day 90
The death due to any cause
Time frame: Day 90

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
Derived from this study: PubMed 41944218Cui Y, Liu JL, Jiang CH, Hou XW, Chen HS. Diabetes Mellitus and Early Antiplatelet Treatment for Minor Stroke Following Intravenous Thrombolysis: Prespecified Secondary Analysis of the EAST Trial. Diabetes Obes Metab. 2026 Jul;28(7):5604-5613. doi: 10.1111/dom.70745. Epub 2026 Apr 7.
Individual participant dataSharing planned: Undecided

Related trials for Ischemic Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites 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 100mg; Clopidogrel 300mg in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 2 sites 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of excellent prognosis (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05193071, which also lists 1 linked publication.

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 31 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.