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Special Drug Use Surveillance of EFIENT Tablet - Prasugrel For Japanese patients with ischemic heart disease in long-term use clinical practice -

Special Drug Use Surveillance of EFIENT Tablet - Prasugrel For Japanese patients with ischemic heart disease in long-term use clinical practice - - PRASFIT-Practice II

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000018003
Enrollment
4000
Registered
2015-06-23
Start date
2015-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with any of the ischemic heart diseases specified below that require PCI: Acute coronary syndrome (unstable angina pectoris, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction), stable angina pectoris, old myocardial infarction.

Interventions

None listed

Sponsors

Daiichi Sankyo Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with any of the ischemic heart diseases specified below that require PCI : Acute coronary syndrome (unstable angina pectoris, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction), stable angina pectoris, old myocardial infarction.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Safety 1) Frequency of adverse drug reactions 2) Frequency of severe adverse events 3) Frequency of bleeding events Efficacy - Frequency of cardiovascular events Special population - Safety and efficacy in patients with hepatic disease, renal disease, and elderly

Countries

Japan

Contacts

Public ContactHIROHIDE OUCHI

Daiichi Sankyo Co., Ltd. Post Marketing Study Department

ouchi.hirohide.bm@daiichisankyo.co.jp+81-3-6225-1044

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026