PMID- 35599000
OWN - NLM
STAT- MEDLINE
DCOM- 20230303
LR  - 20230305
IS  - 1880-3873 (Electronic)
IS  - 1340-3478 (Print)
IS  - 1340-3478 (Linking)
VI  - 30
IP  - 3
DP  - 2023 Mar 1
TI  - 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).
PG  - 222-236
LID - 10.5551/jat.63473 [doi]
AB  - AIM: To examine the efficacy and safety of prasugrel vs clopidogrel in thrombotic 
      stroke patients at risk of ischemic stroke. METHODS: This multicenter, 
      active-controlled, randomized, double-blind, double-dummy, parallel group study 
      enrolled thrombotic stroke patients aged >/= 50 years at risk of ischemic stroke. 
      Patients received prasugrel (3.75 mg/day) or clopidogrel (75 or 50 mg/day) for 
      24-48 weeks; other antiplatelet drugs were prohibited. The primary efficacy 
      endpoint was the composite incidence of ischemic stroke, myocardial infarction 
      (MI), and death from other vascular causes from the start to 1 day after 
      treatment completion or discontinuation. Secondary efficacy endpoints included 
      the incidences of ischemic stroke, MI, death from other vascular causes, ischemic 
      stroke and transient ischemic attack, and stroke. Safety endpoints included 
      bleeding events and adverse events (AEs). RESULTS: In the prasugrel (N=118) and 
      clopidogrel (N=112; all received 75 mg) groups, the primary efficacy endpoint 
      composite incidence (95% confidence interval) was 6.8% (3.0%-12.9%) and 7.1% 
      (3.1%-13.6%), respectively. The risk ratio (prasugrel/clopidogrel) was 0.949 
      (0.369-2.443). Secondary efficacy endpoints followed a similar trend. The 
      combined incidences of life-threatening, major, and clinically relevant bleeding 
      were 5.0% and 3.5% in the prasugrel and clopidogrel groups, respectively. The 
      incidences of all bleeding events and AEs were 19.2% and 24.6% and 76.7% and 
      82.5% in the prasugrel and clopidogrel groups, respectively. No serious AEs were 
      causally related to prasugrel. CONCLUSIONS: We observed a risk reduction of 5% 
      with prasugrel vs clopidogrel, indicating comparable efficacy. There were no 
      major safety issues for prasugrel.
FAU - Kitazono, Takanari
AU  - Kitazono T
AD  - Department of Medicine and Clinical Science, Graduate School of Medical Sciences, 
      Kyushu University.
FAU - Kamouchi, Masahiro
AU  - Kamouchi M
AD  - Department of Health Care Administration and Management, Graduate School of 
      Medical Sciences, Kyushu University.
FAU - Matsumaru, Yuji
AU  - Matsumaru Y
AD  - Division of Stroke Prevention and Treatment, Department of Neurosurgery, Faculty 
      of Medicine, University of Tsukuba.
FAU - Nakamura, Masato
AU  - Nakamura M
AD  - Division of Cardiovascular Medicine, Toho University Ohashi Medical Center.
FAU - Umemura, Kazuo
AU  - Umemura K
AD  - Department of Pharmacology, Hamamatsu University School of Medicine.
FAU - Matsuo, Hajime
AU  - Matsuo H
AD  - Daiichi Sankyo Co., Ltd.
FAU - Koyama, Nobuyuki
AU  - Koyama N
AD  - Daiichi Sankyo Co., Ltd.
FAU - Tsutsumi, Junko
AU  - Tsutsumi J
AD  - Daiichi Sankyo Co., Ltd.
FAU - Kimura, Kazumi
AU  - Kimura K
AD  - Department of Neurological Science, Graduate School of Medicine, Nippon Medical 
      School.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220521
PL  - Japan
TA  - J Atheroscler Thromb
JT  - Journal of atherosclerosis and thrombosis
JID - 9506298
RN  - G89JQ59I13 (Prasugrel Hydrochloride)
RN  - A74586SNO7 (Clopidogrel)
RN  - 0 (Platelet Aggregation Inhibitors)
SB  - IM
MH  - Humans
MH  - Prasugrel Hydrochloride/adverse effects
MH  - Clopidogrel/adverse effects
MH  - *Ischemic Stroke/drug therapy
MH  - Platelet Aggregation Inhibitors/adverse effects
MH  - *Stroke/epidemiology
MH  - *Myocardial Infarction/epidemiology
MH  - Hemorrhage/chemically induced
MH  - Risk Factors
MH  - *Thrombotic Stroke/chemically induced/drug therapy
MH  - Treatment Outcome
MH  - *Acute Coronary Syndrome/drug therapy
PMC - PMC9981351
OTO - NOTNLM
OT  - Clopidogrel
OT  - Phase III
OT  - Prasugrel
OT  - Thrombotic stroke
EDAT- 2022/05/23 06:00
MHDA- 2023/03/04 06:00
PMCR- 2023/03/01
CRDT- 2022/05/22 21:23
PHST- 2022/05/23 06:00 [pubmed]
PHST- 2023/03/04 06:00 [medline]
PHST- 2022/05/22 21:23 [entrez]
PHST- 2023/03/01 00:00 [pmc-release]
AID - DN/JST.JSTAGE/jat/63473 [pii]
AID - 10.5551/jat.63473 [doi]
PST - ppublish
SO  - J Atheroscler Thromb. 2023 Mar 1;30(3):222-236. doi: 10.5551/jat.63473. Epub 2022 
      May 21.