Trial reportCerebrovascular diseases (Basel, Switzerland)2020
Safety and Efficacy of Prasugrel in Elderly/Low Body Weight Japanese Patients with Ischemic Stroke: Randomized PRASTRO-II.
Trial report in Cerebrovascular diseases (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Update on antithrombotic therapy and body mass: a clinical consensus statement of the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy and the European Society of Cardiology Working Group on Thrombosis.European heart journal. Cardiovascular pharmacotherapy · 2024Pooled it
- P2YJournal of atherosclerosis and thrombosis · 2026Trial
- Efficacy and Safety of Prasugrel vs Clopidogrel in Thrombotic Stroke Patients With Risk Factors for Ischemic Stroke Recurrence: A Double-blind, Phase III Study (PRASTRO-III).Journal of atherosclerosis and thrombosis · 2023Trial
- Effectiveness and safety of high dose clopidogrel plus aspirin in ischemic stroke patients with the single CYP2C19 loss-of-function allele: a randomized trial.BMC neurology · 2020Trial
- Retrospective observational analysis of prasugrel dosage afterpercutaneous coronary intervention using the Clinical Deep DataAccumulation System database.Global health & medicine · 2026Article
- Differences in P2YCirculation reports · 2025Article
- Exploring the relationship of platelet aggregation function with efficacy and safety outcomes following the administration of prasugrel and clopidogrel in patients with thrombotic stroke: a post hoc analysis of PRASTRO pooled studies.Journal of thrombosis and thrombolysis · 2025Article
- Clinical Efficacy and Safety of Reduced-Dose Prasugrel After Percutaneous Coronary Intervention for Taiwanese Patients with Acute Coronary Syndromes.Journal of clinical medicine · 2024Article
- Comparing efficacy and safety of low-dose versus standard-dose antiplatelet therapy in stroke patients: a meta-analysis.Frontiers in pharmacology · 2024Review
- Prasugrel for Secondary Prevention of Thrombotic Stroke.Journal of atherosclerosis and thrombosis · 2023Article
- Safety and Efficacy of Low-dose Prasugrel in the Endovascular Treatment of Unruptured Aneurysms in the Elders (≥ 75 Years).Clinical neuroradiology · 2023Article
- Safety and Efficacy of Prasugrel Administration in Emergent Endovascular Treatment for Intracranial Atherosclerotic Disease.Journal of neuroendovascular therapy · 2023Article
- Antiplatelet Use in Ischemic Stroke.The Annals of pharmacotherapy · 2022Review
- Safety of Oral P2Y12 Inhibitors in Interventional Neuroradiology: Current Status and Perspectives.AJNR. American journal of neuroradiology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe safety of prasugrel in elderly and/or low body weight Japanese patients with ischemic stroke who have a relatively high bleeding risk with antiplatelet therapy remains unknown.
objectiveWe aimed to investigate the safety and efficacy of long-term prasugrel monotherapy for stroke prevention compared with clopidogrel in elderly and/or low body weight Japanese patients with non-cardioembolic ischemic stroke.
methodsIn this randomized, double-blind, comparative, phase III study, elderly (age ≥75 years) and/or low body weight (≤50 kg) Japanese patients with a previous history of non-cardioembolic ischemic stroke were assigned to a prasugrel 3.75 mg (PRA3.75) group, a prasugrel 2.5 mg (PRA2.5) group, or a clopidogrel 50 mg (CLO50) group and followed up for 48 weeks. The primary safety endpoint was the combined incidence of primary safety events, defined as life-threatening, major, and other clinically relevant bleeding. The efficacy endpoint was a composite of ischemic stroke, myocardial infarction, and death from other vascular causes.
resultsA total of 654 patients (age 76.4 ± 7.3 years, body weight 55.6 ± 9.3 kg, women 43.9%) from 74 medical institutions within Japan were enrolled. The combined incidence (95% CI) of primary safety events was 4.2% (1.9-7.8%), 1.9% (0.5-4.7%), and 3.6% (1.6-6.9%) in the PRA3.75 group (n = 216), PRA2.5 group (n = 215), and CLO50 group (n = 223), respectively (hazard ratios [HR] PRA3.75/CLO50, 1.13 [0.44-2.93]; PRA2.5/CLO50, 0.51 [0.15-1.69]). The incidences of bleeding leading to treatment discontinuation (95% CI) were 2.3% (0.8-5.3%), 0.9% (0.1-3.3%), and 2.2% (0.7-5.2%) in the PRA3.75, PRA2.5, and CLO50 groups, respectively (HRs PRA3.75/CLO50, 1.01 [0.29-3.48]; PRA2.5/CLO50, 0.41 [0.08-2.12]). There was no significant difference in all bleeding events between groups. The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00-0.00]; PRA2.5/CLO50, 0.90 [0.32-2.47]).
conclusionsElderly and/or low body weight -Japanese patients with previous non-cardioembolic ischemic stroke who received PRA3.75 showed similar results in terms of primary safety endpoint, and a numerically lower incidence of ischemic stroke, myocardial infarction, and death from other vascular causes, compared with those who received CLO50.
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