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Ischemic StrokePhase 4PATH STROKE DNCT07644234

Platelet Aggregation Function-Guided De-Escalation Antiplatelet Therapy in Patients With Acute Ischemic Stroke

A Phase 4 study testing Clopidogrel and Aspirin in people with Ischemic Stroke and Transient Ischemic Attack, run by Sichuan Provincial People's Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This multicenter, prospective, open-label, randomized controlled trial will evaluate whether platelet aggregation function-guided de-escalation of antiplatelet therapy is non-inferior in efficacy and superior in safety compared with standard dual antiplatelet therapy in patients with acute minor ischemic stroke or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Transient Ischemic Attack
What is being tested?
Clopidogrel and Aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,836 participants
Where
1 siteChina
Study dates
Jun 2026to Oct 2029
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Age 18 years or older. 2.Diagnosis of acute non-disabling ischemic stroke or transient ischemic attack according to World Health Organization criteria, meeting one of the following definitions: acute non-disabling ischemic stroke, defined as a National Institutes of Health Stroke Scale score of 5 or lower at enrollment; or high-risk transient ischemic attack, defined as an ABCD2 score of 4 or higher.
  • 3.Symptom onset within 48 hours. Onset time is defined as the interval from the last time the participant was known to be well to the time of combined administration of clopidogrel 300 mg and aspirin 100 mg.
  • 4.MARADP <35% measured 5 to 20 hours after combined antiplatelet treatment with clopidogrel 300 mg and aspirin 100 mg within 48 hours of symptom onset.
  • 5.Planned treatment with aspirin plus clopidogrel or clopidogrel monotherapy for antiplatelet therapy.
  • 6.Written informed consent provided by the participant or a legally authorized representative.
  • Exclusion Criteria:1.Imaging evidence of hemorrhagic stroke, hemorrhagic transformation, or another pathological brain disorder, such as vascular malformation, tumor, abscess, or another common non-ischemic brain disease such as multiple sclerosis.
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  • 2.Minor stroke or transient ischemic attack caused by angioplasty or vascular surgery.
  • 3.Atrial fibrillation indicated by standard electrocardiography or typical physical signs of atrial fibrillation, including absolutely irregular rhythm, variable intensity of the first heart sound, or pulse deficit.
  • 4.A clear indication for anticoagulation, including suspected cardioembolism such as atrial fibrillation, known artificial heart valve, or suspected endocarditis.
  • 5.Intravenous thrombolysis, intra-arterial thrombolysis, mechanical thrombectomy, or any revascularization procedure performed after the index event or planned within 90 days.
  • 6.Use of antiplatelet agents other than aspirin or clopidogrel within 7 days before enrollment, such as ticagrelor or prasugrel.
  • 7.History of gastrointestinal bleeding, intracranial hemorrhage, recent major bleeding or blood transfusion, excluding minor hemoptysis or minor abnormal vaginal bleeding, or other bleeding disorder caused by coagulation dysfunction, such as purpura.
  • 8.Contraindication or intolerance to clopidogrel or aspirin, including known allergy; severe hepatic insufficiency or renal insufficiency; severe heart failure; coagulation disorder or history of systemic bleeding; history of thrombocytopenia or neutropenia; or history of drug-induced hematologic disease or hepatic dysfunction.
  • 9.Leukopenia, defined as white blood cell count <2 x 10^9/L, or thrombocytopenia, defined as platelet count <100 x 10^9/L.
  • 10.Use of heparin or oral anticoagulants within 10 days before enrollment. 11.Severe cardiac, pulmonary, hepatic, or renal dysfunction, or severe comorbid disease such as tumor, chronic airflow disease, severe dementia, or severe heart failure.
  • 12.Female participants of childbearing potential with a negative pregnancy test who refuse to use effective contraception, or women who are pregnant or breastfeeding.
  • 13.Poor compliance or inability to complete study requirements.
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jie Yang Deputy Director of the Department of Neurology contact

+8613678130516

yangjie1126@163.com

China1 site
  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Jie Yang Deputy Director of the Department of Neurology, +86 13678130516, yangjie1126@163.com

Other trials in China

About this study

This multicenter, prospective, open-label, randomized controlled trial will evaluate whether platelet aggregation function-guided de-escalation of antiplatelet therapy is non-inferior in efficacy and superior in safety compared with standard dual antiplatelet therapy in patients with acute minor ischemic stroke or high-risk transient ischemic attack who are sensitive to clopidogrel.

Participants who present within 48 hours of symptom onset and meet the eligibility criteria will receive loading doses of clopidogrel and aspirin, followed by platelet aggregation function testing. Eligible clopidogrel-sensitive participants will be randomized to receive either 7 days of dual antiplatelet therapy followed by clopidogrel monotherapy or standard 21-day dual antiplatelet therapy followed by single antiplatelet therapy. The primary efficacy outcome is new stroke within 90 days after randomization.

Being tested
Clopidogrel, Aspirin
Keywords
Antiplatelet de-escalation, Ischemic Stroke, Platelet function tests, RCT
Medical subject headings
Ischemic Stroke, Ischemic Attack, Transient

What participants receive

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

  • ClopidogrelDrug

    Clopidogrel will be administered according to the assigned antiplatelet strategy. Participants receive a loading dose during screening and then clopidogrel 75 mg orally once daily during the assigned treatment period.

  • AspirinDrug

    Aspirin will be administered according to the assigned antiplatelet strategy. Participants receive aspirin during screening and then aspirin 100 mg orally once daily during the assigned treatment period.

Study groups in NCT07644234
Study groupRoleWhat they receive
Shortened Dual Antiplatelet Therapy (7-Day DAPT → Clopidogrel Monotherapy)ExperimentalParticipants will receive clopidogrel 75 mg orally once daily plus aspirin 100 mg orally once daily on Days 1-7, followed by clopidogrel 75 mg orally once daily on Days 8-90. Antiplatelet therapy after Day 90 will be determined by the treating physician.
Receives: Drug: Clopidogrel; Drug: Aspirin
Standard Dual Antiplatelet Therapy (21-Day DAPT → Single Antiplatelet)Active comparatorParticipants receive clopidogrel 75 mg once daily plus aspirin 100 mg once daily on Days 1-21, followed by clopidogrel 75 mg once daily or aspirin 100 mg once daily on Days 22-90. Therapy after Day 90 is determined by the treating physician.
Receives: Drug: Clopidogrel; Drug: Aspirin

What is being measured

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

  1. Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days

    Measured: within 90 days

Secondary outcomes (6)
  1. New stroke at prespecified follow-up visits

    Measured: At Day 7 or hospital discharge, Day 30 and 1 year after randomization

  2. New vascular events

    Including cardiovascular and cerebrovascular strokes, myocardial infarctions, and vascular deaths.

    Measured: At Day 7 or hospital discharge, Day 30, Day 90, and 1 year after randomization

  3. Modified Rankin Scale score

    The score range of the scale is from 0 to 6. The higher the score, the worse the outcome.

    Measured: At Day 30, Day 90, 1 year, and 2 years after randomization

  4. New ischemic stroke

    Measured: At Day 7 or hospital discharge, Day 30, Day 90, and 1 year after randomization

  5. Worsening of nerve damage (an increase in the NIHSS score by ≥ 4 points compared to the baseline)

    Measured: At 24 hours and at Day 7 or hospital discharge after randomization

  6. Quality of life at day 90 [assessed by the EuroQol - 5 dimension (EQ - 5D) questionnaire]

    It is usually represented by a value between 0 and 1, where 1 represents perfect health, 0 represents death, and the intermediate values reflect different degrees of health status.

    Measured: At Day 90 after randomization

Timeline

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

  1. First posted12 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionOct 2029 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,836 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07644234
Sponsor's protocol ID
IITLX2026028
Acronym
PATH STROKE D
Status last verified
May 2026
First submitted
8 Jun 2026
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Savcic M, Hauert J, Bachmann F, Wyld PJ, Geudelin B, Cariou R. Clopidogrel loading dose regimens: kinetic profile of pharmacodynamic response in healthy subjects. Semin Thromb Hemost. 1999;25 Suppl 2:15-9.

    PubMed 10440417
  • Ma L, Chen W, Pan Y, Yan H, Li H, Meng X, Wang Y, Wang Y. Comparison of VerifyNow, thromboelastography, and PL-12 in patients with minor ischemic stroke or transient ischemic attack. Aging (Albany NY). 2021 Mar 3;13(6):8396-8407. doi: 10.18632/aging.202650. Epub 2021 Mar 3.

    PubMed 33686963
  • Yang Y, Chen W, Pan Y, Yan H, Meng X, Liu L, Wang Y, Wang Y. Ticagrelor Is Superior to Clopidogrel in Inhibiting Platelet Reactivity in Patients With Minor Stroke or TIA. Front Neurol. 2020 Jun 10;11:534. doi: 10.3389/fneur.2020.00534. eCollection 2020.

    PubMed 32587571
  • Tarantini G, Honton B, Paradies V, Lemesle G, Range G, Godin M, Mangin L, Cuisset T, Ruiz-Nodar JM, Brugaletta S, Lhermusier T, Piot C, De Poli F, Macia JC, Motreff P, Madera-Cambero M, Beygui F, Riccini P, Ranc S, Oreglia JA, Vaquerizo B, Poezevara Y, Bouchez D, Smits PC, Cayla G; TARGET-FIRST Investigators. Early Discontinuation of Aspirin after PCI in Low-Risk Acute Myocardial Infarction. N Engl J Med. 2025 Nov 27;393(21):2083-2094. doi: 10.1056/NEJMoa2508808. Epub 2025 Aug 31.

    PubMed 40888726
  • Tarantini G, Smits PC, Lhermusier T, Honton B, Range G, Piot C, Lemesle G, Ruiz Nodar JM, Godin M, Madera Cambero M, Motreff P, Cuisset T, Bouchez D, Poezevara Y, Cayla G. A prospective study comparing short versus standard dual antiplatelet therapy in patients with acute myocardial infarction: design and rationale of the TARGET-FIRST trial. EuroIntervention. 2023 Jun 19;19(3):240-247. doi: 10.4244/EIJ-D-22-01006.

    PubMed 36999409
  • Tavenier AH, Mehran R, Chiarito M, Cao D, Pivato CA, Nicolas J, Beerkens F, Nardin M, Sartori S, Baber U, Angiolillo DJ, Capodanno D, Valgimigli M, Hermanides RS, van 't Hof AWJ, Ten Berg JM, Chang K, Kini AS, Sharma SK, Dangas G. Guided and unguided de-escalation from potent P2Y12 inhibitors among patients with acute coronary syndrome: a meta-analysis. Eur Heart J Cardiovasc Pharmacother. 2022 Aug 11;8(5):492-502. doi: 10.1093/ehjcvp/pvab068.

    PubMed 34459481
  • Kwon TJ, Tantry US, Park Y, Choi YM, Ahn JH, Kim KH, Koh JS, Park JR, Hwang SJ, Kwak CH, Hwang JY, Gurbel PA, Smith SC Jr, Jeong YH. Influence of platelet reactivity on BARC classification in East Asian patients undergoing percutaneous coronary intervention. Results of the ACCEL-BLEED study. Thromb Haemost. 2016 May 2;115(5):979-92. doi: 10.1160/TH15-05-0366. Epub 2016 Jan 21.

    PubMed 26790469
  • Valgimigli M, Choi KH, Giacoppo D, Gragnano F, Kimura T, Watanabe H, Kim HS, Kang J, Park KW, Pettersen AA, Woodward M, Bhatt DL, Calabro P, Angiolillo DJ, Mehran R, Song YB, Hahn JY. Clopidogrel versus aspirin for secondary prevention of coronary artery disease: a systematic review and individual patient data meta-analysis. Lancet. 2025 Sep 13;406(10508):1091-1102. doi: 10.1016/S0140-6736(25)01562-4. Epub 2025 Aug 31.

    PubMed 40902613
  • Kaushik A, Deora S, Choudhary R. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA. N Engl J Med. 2020 Oct 22;383(17):1692-1693. doi: 10.1056/NEJMc2027491. No abstract available.

    PubMed 33085879
  • Gao Y, Chen W, Pan Y, Jing J, Wang C, Johnston SC, Amarenco P, Bath PM, Jiang L, Yang Y, Wang T, Han S, Meng X, Lin J, Zhao X, Liu L, Zhao J, Li Y, Zang Y, Zhang S, Yang H, Yang J, Wang Y, Li D, Wang Y, Liu D, Kang G, Wang Y, Wang Y; INSPIRES Investigators. Dual Antiplatelet Treatment up to 72 Hours after Ischemic Stroke. N Engl J Med. 2023 Dec 28;389(26):2413-2424. doi: 10.1056/NEJMoa2309137.

    PubMed 38157499
  • Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.

    PubMed 23803136
  • Depta JP, Fowler J, Novak E, Katzan I, Bakdash S, Kottke-Marchant K, Bhatt DL. Clinical outcomes using a platelet function-guided approach for secondary prevention in patients with ischemic stroke or transient ischemic attack. Stroke. 2012 Sep;43(9):2376-81. doi: 10.1161/STROKEAHA.112.655084. Epub 2012 Jun 19.

    PubMed 22713488
  • Yi X, Lin J, Wang C, Huang R, Han Z, Li J. Platelet function-guided modification in antiplatelet therapy after acute ischemic stroke is associated with clinical outcomes in patients with aspirin nonresponse. Oncotarget. 2017 Nov 7;8(63):106258-106269. doi: 10.18632/oncotarget.22293. eCollection 2017 Dec 5.

    PubMed 29290946
  • Kim HS, Kang J, Hwang D, Han JK, Yang HM, Kang HJ, Koo BK, Rhew JY, Chun KJ, Lim YH, Bong JM, Bae JW, Lee BK, Park KW; HOST-REDUCE-POLYTECH-ACS investigators. Prasugrel-based de-escalation of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (HOST-REDUCE-POLYTECH-ACS): an open-label, multicentre, non-inferiority randomised trial. Lancet. 2020 Oct 10;396(10257):1079-1089. doi: 10.1016/S0140-6736(20)31791-8. Epub 2020 Aug 31.

    PubMed 32882163
  • Venketasubramanian N, Agustin SJ, Padilla JL, Yumul MP, Sum C, Lee SH, Ponnudurai K, Gan RN. Comparison of Different Laboratory Tests to Identify "Aspirin Resistance" and Risk of Vascular Events among Ischaemic Stroke Patients: A Double-Blind Study. J Cardiovasc Dev Dis. 2022 May 12;9(5):156. doi: 10.3390/jcdd9050156.

    PubMed 35621867

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel and Aspirin in people with Ischemic Stroke and Transient Ischemic Attack, run by Sichuan Provincial People's 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 18 inclusion and 0 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 12 Jun 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 Jie Yang Deputy Director of the Department of Neurology (+8613678130516, yangjie1126@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days (time frame: within 90 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 NCT07644234, which also lists 37 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 12 Jun 2026.

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