What is the clinical evidence from this study?

Study design: Cohort. Population: Patients with ischemic stroke receiving secondary prevention monotherapy with clopidogrel (generic or brand-name) starting ≥91 days after hospital discharge (n=11082). Intervention: Generic clopidogrel (Thrombifree) vs. Brand-name clopidogrel (Plavix®). Primary outcome: Recurrent ischemic stroke (SHR 1.09, 95% CI 0.97–1.21, p=0.152).

What does this research mean for the field?

Generic clopidogrel demonstrates similar efficacy and safety to brand-name clopidogrel for the secondary prevention of recurrent ischemic stroke, with no significant difference in recurrent stroke or major bleeding risk. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To compare the efficacy and safety of a generic formulation of clopidogrel with brand-name clopidogrel for preventing recurrent ischemic strokes.

February 28, 2026BMC Neurology0 citationsOpen Access

Clinical outcomes of a generic versus brand-name clopidogrel for secondary prevention in patients with ischemic stroke: a nationwide retrospective cohort study

CCChing-Jung Chen CHChia-Hao Hung FHFu-Chih Hsiao

Key Result

Generic clopidogrel demonstrated similar efficacy to brand-name clopidogrel for preventing recurrent ischemic stroke with incidence rates of 3.95 vs 3.43 per 100 person-years and no significant difference (SHR 1.09, 95% CI 0.97–1.21, P=0.152).

Key Points

To compare the efficacy and safety of a generic formulation of clopidogrel with brand-name clopidogrel for preventing recurrent ischemic strokes.
Retrospective cohort study design
Analysis of Taiwan National Health Insurance Database from 2008 to 2021
Included patients prescribed either generic or brand-name clopidogrel
Utilized 1:1 propensity score matching to reduce confounding effects
Analyzed 5,540 matched pairs of patients.
Incidence rate of recurrent ischemic stroke was 3.95 per 100 person-years in the generic group
Incidence rate in the brand-name group was 3.43 per 100 person-years
Subdistribution hazard ratio (SHR) was 1.09 (95% CI 0.97–1.21) showing no significant difference
Risk of major bleeding was similar between both groups
No significant differences in secondary cardiovascular or bleeding endpoints were observed.

Study Design

Type

Cohort (n=11,082)

Multicenter

Yes

Structured PICO

Does generic clopidogrel provide similar efficacy and safety compared to brand-name clopidogrel for long-term secondary prevention in patients with ischemic stroke?

Population

11,080 matched patients (from an initial cohort of 100,206) hospitalized for ischemic stroke or transient ischemic attack, aged ≥18 years, mean age ~71, ~61% male, in Taiwan. Excluded patients with atrial fibrillation, rheumatic valvular disorders, prior mechanical valve replacement, or recent exposure to oral anticoagulants.

Intervention

Generic clopidogrel 75 mg oral daily as long-term monotherapy (initiated ≥91 days after hospital discharge).

Comparator

Brand-name clopidogrel 75 mg oral daily as long-term monotherapy.

Outcome

Recurrent acute ischemic stroke (efficacy) and major bleeding defined as any hemorrhagic episode requiring hospitalization or resulting in death within 7 days (safety).hard clinical

Generic clopidogrel demonstrated similar long-term efficacy and safety profiles compared to brand-name clopidogrel for secondary prevention in patients with ischemic stroke.

Main Result

Effect estimate: SHR 1.09 (95% CI 0.97–1.21)

Absolute Event Rate: 3.95% vs 3.43%

p-value: p=0.152

Limitations

Retrospective observational design with potential residual confounding despite propensity score matching
Lack of laboratory and vital sign data such as platelet reactivity or NIHSS score not directly measured but estimated
Possible misclassification bias due to claims data nature
Study focused on a specific generic formulation approved and used in Taiwan, limiting generalizability

Abstract

Stroke is a leading cause of death and disability worldwide. Clopidogrel, an antiplatelet agent that is commonly used for the secondary prevention of ischemic stroke, yet the data on the efficacy and safety of generic versus brand-name clopidogrel remain limited. The aim of this retrospective cohort study was to compare the efficacy and safety of a specific generic formulation of clopidogrel (Thrombifree) with brand-name clopidogrel during the long-term monotherapy phase, initiated ≥ 91 days after hospital discharge, in the secondary prevention of ischemic stroke. Patients with ischemic stroke prescribed either generic or brand-name clopidogrel were identified from the Taiwan National Health Insurance Research Database between 2008 and 2021. The efficacy was defined as recurrent ischemic stroke and safety as major bleeding. Possible confounding effects were reduced using 1:1 propensity score matching. A total of 5,540 matched pairs were included in the analysis. The incidence rate of recurrent ischemic stroke was 3.95 per 100 person-years in the generic group, and 3.43 per 100 person-years in the brand-name group (subdistribution hazard ratio SHR 1.09, 95% confidence interval CI 0.97–1.21). The risk of major bleeding was also similar between the two groups. No significant differences were observed in other secondary cardiovascular or bleeding endpoints. This study showed that the specific generic clopidogrel formulation evaluated in this study demonstrated similar efficacy and safety profiles compared with the brand-name product in patients with ischemic stroke, with no statistically significant differences observed.

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