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.

Not Applicable

• Conditions: Acute Coronary Syndromes

• Registration Number: JPRN-UMIN000002940
• Lead Sponsor: Division of Cardiology, Yokohama City University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-04
• Study Completion: 2014-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.