Low-dose ticagrelor combined with aspirin in the prevention of early neurological deterioration of high-risk non-disabling ischemic cerebrovascular events: a PROBE clinical study

Q: What is the clinical evidence from this study?

Study design: RCT. Population: High-risk non-disabling ischemic cerebrovascular events (HR-NICE) (n=240). Intervention: Low-dose ticagrelor combined with aspirin vs. Clopidogrel 300 mg and aspirin 100 mg on day 1, then clopidogrel 75 mg daily and aspirin 100 mg daily for 21 days, then aspirin 100 mg daily. Primary outcome: Early neurological deterioration within 7 days (new neurological deficits or an increase in the NIHSS score of ≥ 2 points).

Mingli Wang; Rui Chen; Xinting Yu; Xing Gong; Xidan Li; Xiaofei Ji; Jingshun Shen; Hua Cao; Lanlan Pu

doi:10.1186/s13063-026-09691-7

April 6, 2026TrialsOpen Access

Low-dose ticagrelor combined with aspirin in the prevention of early neurological deterioration of high-risk non-disabling ischemic cerebrovascular events: a PROBE clinical study

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Key result

Low-dose ticagrelor plus aspirin seeks non-inferiority to clopidogrel plus aspirin for preventing early neurological deterioration.

n=240

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Why the study?

Ticagrelor combined with aspirin improves prognosis in high-risk non-disabling cerebrovascular events (HR-NICE) but carries a relatively high bleeding risk.

Does low-dose ticagrelor combined with aspirin prevent early neurological deterioration in patients with high-risk non-disabling cerebrovascular events compared to clopidogrel combined with aspirin?

Key Points

To assess whether dual antiplatelet therapy using low-dose ticagrelor combined with aspirin effectively prevents early neurological deterioration compared with clopidogrel plus aspirin in patients with high-risk non-disabling ischemic cerebrovascular events.
A multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) noninferiority trial enrolling 240 patients with high-risk non-disabling cerebrovascular events who have not undergone reperfusion therapy (registered as ChiCTR2300068509).
Participants are block-randomized 1:1 to either ticagrelor (120 mg loading, then 60 mg twice daily) plus aspirin (100 mg daily) or clopidogrel (300 mg loading, then 75 mg daily) plus aspirin (100 mg daily) for 21 days, followed by aspirin monotherapy.
The primary efficacy outcome is early neurological deterioration within 7 days, and primary safety endpoints comprise any bleeding events and all-cause mortality.
Primary clinical outcome efficacy data are currently pending completion of the trial protocol.
The trial tests whether low-dose ticagrelor overcomes CYP2C19 loss-of-function resistance commonly seen with clopidogrel while minimizing excess bleeding risks during acute non-disabling stroke management.

Study Design

Type

RCT (n=240)

Blinding

Open-label, blinded endpoints (PROBE)

Randomization

Block randomization (1:1 ratio)

Multicenter

Yes

Structured PICO

Does low-dose ticagrelor combined with aspirin prevent early neurological deterioration in patients with high-risk non-disabling cerebrovascular events compared to clopidogrel combined with aspirin?

P

Population

240 patients with high-risk non-disabling cerebrovascular events (HR-NICE) who have not undergone reperfusion therapy

I

Intervention

Ticagrelor (120 mg on day 1, then 60 mg twice daily) combined with aspirin (100 mg daily) for 21 days, followed by aspirin 100 mg daily

C

Comparator

Clopidogrel (300 mg on day 1, then 75 mg daily) combined with aspirin (100 mg daily) for 21 days, followed by aspirin 100 mg daily

O

Outcome

Early neurological deterioration within 7 dayshard clinical

This study protocol describes a randomized trial comparing low-dose ticagrelor plus aspirin versus clopidogrel plus aspirin for preventing early neurological deterioration in patients with high-risk non-disabling ischemic cerebrovascular events.

Limitations

This is a study protocol, so no clinical results or findings are currently available.
The study utilizes an open-label design, which may introduce bias despite blinded endpoint adjudication.

Implication

Should not yet change DAPT practice in high-risk non-disabling events; this RCT protocol extends evidence by testing low-dose ticagrelor versus clopidogrel for END prevention.

Abstract

Early neurological deterioration (END) seriously endangers the clinical prognosis of high-risk non-disabling cerebrovascular events (HR-NICE), and strong antiplatelet therapy is an effective means of preventing the occurrence of END. Studies have confirmed that ticagrelor can avoid the low efficacy of clopidogrel in antiplatelet therapy caused by CYP2C19 gene dysfunction and that its combination with aspirin can improve the clinical prognosis of patients with HR-NICE. However, the overall risk of bleeding events is relatively high. In this protocol, we compared the prevention and safety of END in patients with HR-NICE using aspirin combined with low-dose ticagrelor and aspirin combined with clopidogrel. This multicenter, prospective, randomised, open-label, blinded endpoints (PROBE) clinical study intended to enrol 240 patients with HR-NICE who have not undergone reperfusion therapy for block randomization. Ticagrelor combined with aspirin group (120 cases): the patients were given 120 mg of ticagrelor and 100 mg of aspirin orally on the first day of enrollment, and from the next day onwards, ticagrelor 60 mg twice daily orally and aspirin 100 mg daily orally. The clopidogrel combined with aspirin group (120 cases) was administered 300 mg clopidogrel and 100 mg aspirin orally on the first day of enrollment, and starting from the next day, 75 mg clopidogrel and 100 mg aspirin were administered orally. After 21 days, all patients were changed to aspirin 100 mg daily orally. The main efficacy outcome is the early neurological deterioration within 7 days. Safety outcomes include any bleeding events and death. This non-inferiority trial will explore whether low-dose ticagrelor combined with aspirin is superior to clopidogrel combined with aspirin for the prevention of END in patients with HR–NICE patients. Ethics approval was obtained from the Ethics Committee of The First Affiliated Hospital of Dalian Medical University (Number Project ID PJ-KS-KY-2023-03(X)). The research results will be published as a journal article. Chinese Clinical Trial Registry, ChiCTR2300068509. Registered on February 21, 2023. https://www.chictr.org.cn/.

Discussion

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Cite This Study

Wang et al. (2026) conducted an RCT in High-risk non-disabling ischemic cerebrovascular events (HR-NICE) (n=240). Low-dose ticagrelor combined with aspirin vs. Clopidogrel 300 mg and aspirin 100 mg on day 1, then clopidogrel 75 mg daily and aspirin 100 mg daily for 21 days, then aspirin 100 mg daily was evaluated on Early neurological deterioration within 7 days (new neurological deficits or an increase in the NIHSS score of ≥ 2 points). Low-dose ticagrelor combined with aspirin will be evaluated against clopidogrel combined with aspirin for the prevention of early neurological deterioration in a non-inferiority trial of 240 patients with high-risk non-disabling ischemic cerebrovascular events.

synapsesocial.com/papers/69d5f05d74eaea4b11a79cca https://doi.org/10.1186/s13063-026-09691-7

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Low-dose ticagrelor combined with aspirin in the prevention of early neurological deterioration of high-risk non-disabling ischemic cerebrovascular events: a PROBE clinical study

Figures

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Low-dose ticagrelor combined with aspirin in the prevention of early neurological deterioration of high-risk non-disabling ischemic cerebrovascular events: a PROBE clinical study

Figures

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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