Cardiovascular Intervention and Therapeutics

, Volume 29, Issue 2, pp 123–133 | Cite as

Japanese postmarketing surveillance of clopidogrel for patients with non-ST-segment-elevation acute coronary syndrome indicated for percutaneous coronary intervention (J-PLACE NSTE-ACS)

  • Yoshihiro Morino
  • Junya Ako
  • Masayuki Kobayashi
  • Masato Nakamura
Original Article


Clopidogrel in combination with aspirin has been a standard therapy for patients who have undergone percutaneous coronary intervention. The present study was conducted as a postmarketing surveillance, for the purpose of assessing the safety and efficacy of clopidogrel in real clinical practice in patients with non-ST-segment-elevation acute coronary syndrome (NSTE-ACS). Subjects were registered between March 2008 and December 2010, and as a result, patients not only with NSTE-ACS but also other types of ischemic heart diseases were enrolled. Data on off-label subjects were used only in safety evaluation. After excluding patients with inappropriate clinical report forms, 3,673 patients with non-ST-segment-elevation myocardial infarction, unstable angina, STEMI, stable angina, or old myocardial infarction were observed for safety evaluation. Efficacy was assessed in 2,562 of the 3,673 patients with NSTE-ACS. Aspirin was concomitantly prescribed to 3,615/3,673 (98.6 %) of the safety group, and 2,374/3,673 (64.6 %) received a loading dose of clopidogrel. During a maximum follow-up period of 12 months, 397 (10.8 %) of the 3,673 patients experienced adverse drug reactions (ADRs), of whom 145 (4.0 %) had serious conditions, as classified by the investigators. The most frequently observed ADRs were hepatobiliary and gastrointestinal disorders. Bleeding adverse events were observed in 138 patients (3.8 %) and 80 cases (2.2 %) were considered as serious. The 1-year cumulative incidence of major adverse cardiovascular events and major adverse cardiac and cerebrovascular events in the patients with NSTE-ACS were estimated to be 11.6 and 12.2 %, respectively. Serious AEs that substantially affect the safety profile of clopidogrel were not confirmed.


Clopidogrel Postmarketing surveillance NSTE-ACS 



This study was funded by Sanofi K.K. The authors thank all the investigators, staffs, and patients who contributed to this postmarketing surveillance.

Conflict of interest

YM, JA and MN received remuneration (e.g. lecture fees) from Sanofi K.K. YM and MN received research funding from Sanofi K.K. MK is an employee of Sanofi K.K.

Supplementary material

12928_2013_229_MOESM1_ESM.doc (406 kb)
Supplementary material 1 (DOC 406 kb)


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Copyright information

© Japanese Association of Cardiovascular Intervention and Therapeutics 2013

Authors and Affiliations

  • Yoshihiro Morino
    • 1
  • Junya Ako
    • 2
  • Masayuki Kobayashi
    • 3
  • Masato Nakamura
    • 4
  1. 1.Division of Cardiology, Department of Internal MedicineIwate Medical UniversityMoriokaJapan
  2. 2.Department of Cardiovascular MedicineKitasato UniversityKanagawaJapan
  3. 3.Medical OperationsTokyoJapan
  4. 4.Division of Cardiovascular MedicineToho University Ohashi Medical CenterTokyoJapan

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