An association between post-treatment platelet reactivity and ischemic and bleeding events after stent implantation in patients with acute coronary syndromes: A multicenter, prospective, cohort study.

An association between post-treatment platelet reactivity and ischemic and bleeding events after stent implantation in patients with acute coronary syndromes: A multicenter, prospective, cohort study. - Platelet function monitoring in patients with acute coronary syndromes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000002940

Enrollment

360

Registered

2010-01-04

Start date

2010-01-01

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

Acute Coronary Syndromes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with acute coronary syndromes who are scheduled to undergo coronary stent implantation treated with aspirin and clopidogrel are enrolled.

Exclusion criteria

Exclusion criteria: 1) use of warfarin, ticlopidine, cilostazole, glycoprotein IIb/IIIa inhibitor, or fibrinolytics within 7 days before enrollment or duing study period. 2) serum hemoglobin level <10 g/dl or >18 g/dl 3) platelet count <100,000 /mm3 or >500,000 /mm3 4) hematologic or malignant disordor 5) major bleeding events within 7 days before enrollment 6) severe chronic renal failure (serum creatinine > 2mg/dl) 7) severe liver dysfunction (hepatic cirrhosis or portal hypertension) 8) acute coronary syndromes caused by stent thrombosis or in-stent restenosis 9) drug allergy of aspirin or clopidogrel 10) participating in the other trial (phase 1-3) 11) women of pregnant, childbearing potential or lactation 12) patients who are not allowed to participate in the trial by judgement of the treating physician

Design outcomes

Primary

Measure	Time frame
1) Frequency of 1-year composite endpoints (including cardiovascular death, myocardial infarction, stent thrombosis, target vessel revascularization, non-target vessel revascularization, and ischemic stroke and major bleeding) in the first quartile group, the fourth, and the other 2 quartiles according to post-treatment platelet reactivity assessed by VerifyNow P2Y12 assay before PCI. Myocardial infarction is defined as universal definition in 2007, stent thrombosis is defined as ARC definition(definite, probable, possible), and major bleeding is defined as REPLACE-2 criteria.	—

Measure

Time frame

1) Frequency of 1-year composite endpoints (including cardiovascular death, myocardial infarction, stent thrombosis, target vessel revascularization, non-target vessel revascularization, and ischemic stroke and major bleeding) in the first quartile group, the fourth, and the other 2 quartiles according to post-treatment platelet reactivity assessed by VerifyNow P2Y12 assay before PCI. Myocardial infarction is defined as universal definition in 2007, stent thrombosis is defined as ARC definition(definite, probable, possible), and major bleeding is defined as REPLACE-2 criteria.

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Secondary

Measure	Time frame
1) Frequency of 1-year adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, stent thrombosis, target vessel revascularization, non-target vessel revascularization, and ischemic stroke) and major bleeding in patients with high post-treatment platelet reactivity before PCI. High post-treatment platelet reactivity is defined as P2Y12 reaction unit (PRU) >= 235 assessed by VerifyNow P2Y12 assay before PCI.	—

Measure

Time frame

1) Frequency of 1-year adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, stent thrombosis, target vessel revascularization, non-target vessel revascularization, and ischemic stroke) and major bleeding in patients with high post-treatment platelet reactivity before PCI. High post-treatment platelet reactivity is defined as P2Y12 reaction unit (PRU) >= 235 assessed by VerifyNow P2Y12 assay before PCI.

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Countries

Japan

Contacts

Public ContactKengo Tsukahara

Yokohama City University Medical Center Division of Cardiology

k-tsuka@urahp.yokohama-cu.ac.jp045-261-5656

Outcome results