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StrokePhase 4ARAMISNCT03661411

Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke

A Phase 4 study testing Aspirin, Clopidogrel 75mg and Alteplase in people with Stroke, run by General Hospital of Shenyang Military Region at 1 site 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

Acute ischemic stroke (AIS) is one of common diseases with significant morbidity, mortality and disability. A wide array of studies confirms that intravenous thrombolytic therapy with alteplase can effectively improve the functional prognosis in acute ischemic stroke. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Aspirin, Clopidogrel 75mg and Alteplase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
760 participants
Where
1 siteChina
Study dates
17 Oct 2018to 18 Jul 2022
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

  • Patient age ≥18 years;
  • Study treatment can be started within 4.5h;
  • Ischemic stroke confirmed by head CT or MRI;
  • NIHSS score ≤ 5, and ≤ 1 NIHSS score in single item scores such as vision, language, neglect and single limb and no score in consciousness item;
  • Premorbid mRS ≤ 1;
  • Signed informed consent

Who cannot join

  • Serious neurological deficits before onset ( mRS ≥ 2)；
  • Obvious head injuries or strokes within 3 months；
  • Subarachnoid hemorrhage;
  • History of intracranial hemorrhage;
  • Intracranial tumor, arteriovenous malformation or aneurysm;
  • Intracranial or spinal cord surgery within 3 months;
Show all 24Show fewer
  • Arterial puncture at a noncompressible site within the previous seven days;
  • Gastrointestinal or urinary tract hemorrhage within the previous 21 days;
  • Major surgery within 1 month;
  • Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
  • Blood glucose < 50 mg/dl (2.7mmol/L);
  • Heparin therapy or oral anticoagulation therapy within 48 hours;
  • Platelet count of <100,000/mm3 (This does not need to be verified prior to randomization if clinical abnormality is not suspected);
  • Oral warfarin is being taken and INR>1.6;
  • Abnormal APTT;
  • Pregnancy;
  • Neurological deficit after epileptic seizures;
  • Myocardial infarction within 3 months;
  • Cerebral infarction with definite anticoagulation indications, such as cerebral infarction caused by cardiogenic embolism;
  • Oral administration is not allowed due to dysphagia;
  • allergy to study drugs;
  • Other serious illness that would confound the clinical outcome at 90 days;
  • Participating in other clinical trials within 3 months;
  • patients not suitable for this clinical studies considered by researcher;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Lin Tao

    Shenyang

Other trials in China

About this study

Official title: Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke: a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study

Acute ischemic stroke (AIS) is one of common diseases with significant morbidity, mortality and disability. A wide array of studies confirms that intravenous thrombolytic therapy with alteplase can effectively improve the functional prognosis in acute ischemic stroke. Thus all guidelines recommended the intravenous thrombolytic therapy with alteplase for acute ischemic stroke within 4.5 hours from stroke onset.

Minor stroke is usually defined as NIHSS score ≤ 3 or 5，although it accounts for 1/2-2/3 of AIS, the evidence of thrombolysis is insufficient. A study from Canada shows that 28.5% of patients with minor stroke who have not receive rt-pa thrombolytic therapy are unable to walk independently when discharged. Based on such a consideration,the PRISMS study further compares the efficacy and safety of thrombolytic therapy with antithrombotic therapy in patients with minor stroke. Unfortunately, the study has been early terminated due to the sponsorship reason in 2018, with only 313 cases enrolled. The preliminary results shows that there is no significant difference of the 90-day neurological function between the two groups, while the safety of the treatment group with alteplase has a higher rate of symptomatic intracranial hemorrhage. The patient receiving thrombolysis can not be given antithrombolytic therapy within 24 hours even if the patient's condition has worsened, is clinically more puzzling.

Read more

The CHANCE study in 2013 shows that the efficacy of aspirin with clopidogrel is superior to aspirin alone with minor stroke (NIHSS < 3) or TIA(ABCD2 < 4). The POINT study in 2018 further confirmed the efficacy and safety of intensive antithrombotic therapy within 12 hours of onset with minor stroke.

Based on the above discussion, this study aims to explore the efficacy and safety of aspirin with clopidogrel vs alteplase in the treatment of acute minor stroke.

Conditions
Stroke
Being tested
Aspirin, Clopidogrel 75mg, Alteplase
Medical subject headings
Stroke

What participants receive

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

  • AspirinDrug

    100mg qd

  • Clopidogrel 75mgDrug

    75mg（after first dose of 300mg）qd

  • AlteplaseDrug

    Iv at 0.9 milligrams per kilogram (mg/kg)

Study groups in NCT03661411
Study groupRoleWhat they receive
Aspirin+ clopidogrelExperimentalaspirin 100mg qd and clopidogrel 75mg（300mg in the first day）qd with a total of 10-14 days, then oral aspirin 100mg or clopidogrel 75mg qd lasting for 90 days.
Receives: Drug: Aspirin; Drug: Clopidogrel 75mg
AlteplaseActive comparatorintravenous alteplase (0.9 mg/kg and maximal dose of 90 mg) was given, and followed by antithrombotic protocol 24 hours after thrombolysis based on clinical guideline.
Receives: Drug: Alteplase

What is being measured

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

  1. Proportion of mRS (0-1）

    Measured: 90±7 days

Secondary outcomes (8)

  1. Proportion of mRS (0-2）

    Measured: 90±7 days

  2. change in NIH Stroke Scale score compared with baseline

    Measured: 24 hours

  3. incidence of early neurological improvement

    more than 2 NIH Stroke Scale score decrease compared with baseline

    Measured: 24 hours

  4. Incidence of early neurological deterioration

    more than 2 NIH Stroke Scale score increase (not result of cerebral hemorrhage) compared with baseline

    Measured: 7 days

  5. occurrence of stroke or other vascular events

    Measured: 90±7 days

  6. proportion of death of any cause

    Measured: 90±7 days

  7. occurrence of symptomatic intracranial hemorrhage

    more than 4 NIHSS score increase caused by intracranial hemorrhage

    Measured: 90±7 days

  8. proportion of any bleeding events

    Measured: 90±7 days

Timeline

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

  1. First posted7 Sep 2018
  2. Study start17 Oct 2018
  3. Primary completion18 Jul 2022
  4. Study completion18 Jul 2022

Resources

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
760 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03661411
Sponsor's protocol ID
k（2018）22-1
Acronym
ARAMIS
Status last verified
Aug 2022
First submitted
5 Sep 2018
Last updated
3 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yao ZG, Pei YF, Chen HS. Onset to Treatment Time and Early Neurological Deterioration of Dual Antiplatelet Therapy Versus Alteplase in Minor Stroke. J Am Heart Assoc. 2025 Nov 4;14(21):e043980. doi: 10.1161/JAHA.125.043980. Epub 2025 Oct 23.

    PubMed 41128284

  • Fei ZX, Yin Y, Cui Y, Nguyen TN, Chen HS. Dual Antiplatelet Therapy Versus Alteplase for Mild Stroke with Admission NIHSS Score 0-3 Versus 4-5: A Secondary Analysis of the ARAMIS Randomized Trial. CNS Drugs. 2025 Oct;39(10):1037-1046. doi: 10.1007/s40263-025-01211-6. Epub 2025 Aug 4.

    PubMed 40760234

  • He XY, He C, Chen HS. Renal function and efficacy of dual antiplatelet vs. alteplase in minor stroke: a post hoc analysis of ARAMIS study. Front Neurol. 2025 Apr 30;16:1568711. doi: 10.3389/fneur.2025.1568711. eCollection 2025.

    PubMed 40371069

  • Cui Y, Chen HS. Dual antiplatelet versus alteplase in anterior and posterior circulation minor stroke. Stroke Vasc Neurol. 2025 Aug 26;10(4):491-498. doi: 10.1136/svn-2024-003705.

    PubMed 39663175

  • Cui Y, He C, Li ZA, Wang Y, Chen HS. Dual Antiplatelet Versus Alteplase for Early Neurologic Deterioration in Minor Stroke With Versus Without Large Vessel Occlusion: Prespecified Post Hoc Analysis of the ARAMIS Trial. Stroke. 2024 Nov;55(11):2590-2598. doi: 10.1161/STROKEAHA.124.048248. Epub 2024 Oct 10.

    PubMed 39387110

  • Cui Y, Zhao ZA, Wang JQ, Qiu SQ, Shen XY, Li ZY, Hu HZ, Chen HS. Systolic blood pressure and early neurological deterioration in minor stroke: A post hoc analysis of ARAMIS trial. CNS Neurosci Ther. 2024 Jul;30(7):e14868. doi: 10.1111/cns.14868.

    PubMed 39014552

  • Chen HS, Cui Y, Zhou ZH, Zhang H, Wang LX, Wang WZ, Shen LY, Guo LY, Wang EQ, Wang RX, Han J, Dong YL, Li J, Lin YZ, Yang QC, Zhang L, Li JY, Wang J, Xia L, Ma GB, Lu J, Jiang CH, Huang SM, Wan LS, Piao XY, Li Z, Li YS, Yang KH, Wang DL, Nguyen TN; ARAMIS Investigators. Dual Antiplatelet Therapy vs Alteplase for Patients With Minor Nondisabling Acute Ischemic Stroke: The ARAMIS Randomized Clinical Trial. JAMA. 2023 Jun 27;329(24):2135-2144. doi: 10.1001/jama.2023.7827.

    PubMed 37367978

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin, Clopidogrel 75mg and Alteplase in people with Stroke, run by General Hospital of Shenyang Military Region 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 6 inclusion and 24 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 3 Aug 2022. 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?

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?

Proportion of mRS (0-1） (time frame: 90±7 days). 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 NCT03661411, which also lists 7 linked publications.

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 3 Aug 2022.

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