Efficacy and Safety of Low Dose Prasugrel in Japanese Acute Coronary Syndrome Patients: A Single-center Prospective Clinical Trial

Efficacy and Safety of Low Dose Prasugrel in Japanese Acute Coronary Syndrome Patients: A Single-center Prospective Clinical Trial - Efficacy and Safety of Low Dose Prasugrel

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019164

Enrollment

250

Registered

2015-09-30

Start date

2014-08-28

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

Acute Coronary Syndrome

Interventions

In patients after percutaneous coronary intervention with low body weight (body weight 50 kg or under), older age (75 years old or over), or renal insufficiency (eGFR 30 ml/min/1.73m2 or under), the l

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) adult patients receiving percutaneous coronary intervention with acute coronary syndrome (2) patients with low body weight (body weight 50 kg or under), elderly (75 years old or over), or renal insufficiency (eGFR 30 ml/min/1.73m2 or under)

Exclusion criteria

Exclusion criteria: (1) bleeding patients (hemophilia, cerebral bleeding, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, or vitreous hemorrhage) (2) hypersensitive patients for prasugrel in past times (Relative exclusion criteria) (1) patients with cerebral bleeding or critical bleeding (BARC classification 3 or greater) (2) patients with past history of cerebral infarction or transient ischemic attack (3) patients with anticoagulant therapy or scheduled for anticoagulant therapy (4) patients with thienopyridine therapy already

Design outcomes

Primary

Measure	Time frame
MACCE(major adverse cardiovascular and cerebral event) until coronray angiography examination at eight months after index procedure: all-cause death, cardiac death, non-fatal myocardial infarction, non-fatal cerebrovascular events, any revascularization, target lesion revascularization, stent thrombosis	—

Secondary

Measure	Time frame
in-hospital and out-hospital bleeding (until coronray angiography examination at eight months after index procedure), major bleeding not related to coronary artery bypass graft (BARC classification type 3 or greater), minor bleeding (BARC classification type 2 or less), cessation of antiplatelet drug according to bleeding events	—

Countries

Japan

Contacts

Public ContactMasanobu Ohya

Kurashiki Central Hospital Department of Cardiology

mo13590@kchnet.or.jp086-422-0210

Outcome results

None listed

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