Acute Coronary Syndromes
Conditions
Interventions
After baseline assessment of platelet function, patients were randomly assigned by computer-generated randomization sequence to receive omeprazole 10mg once daily for at least 4 weeks. All patients a
Sponsors
Division of Cardiology, Yokohama City University Medical Center
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 proton-pump inhibitors, H2-receptor antagonists, 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) past history of recent gastric or duodenal ulcer 6) major bleeding events within 7 days before enrollment 7) severe chronic renal failure (serum creatinine > 2mg/dl) 8) severe liver dysfunction (hepatic cirrhosis or portal hypertension) 9) acute coronary syndromes caused by stent thrombosis or in-stent restenosis 10) drug allergy of study drugs, aspirin or clopidogrel 11) participating in the other trial (phase 1-3) 12) women of pregnant, childbearing potential or lactation 13) patients who are not allowed to participate in the trial by judgement of the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Incidence of antiplatelet drugs resistance at 14-28 day treatment period in the 2 groups. Antiplatelet drugs resistance is defined as platelet reactivity index (PRI)>=50% assessed by VASP phosphoprotein analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of antiplatelet drugs resistance at 14-28 day treatment period in the 2 groups. Antiplatelet drugs resistance is defined as P2Y12 reaction unit (PRU) >=235 assessed by VerifyNow P2Y12 assay. 2) 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). 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. 3) Frequency of 30-day symptom of upper gastrointestinal damage such as epigastric pain, heartburn, nausea, vomiting, hematemesis, or bloody stool (tarry stool) | — |
Countries
Japan
Contacts
Public ContactKengo Tsukahara
Yokohama City University Medical Center Division of Cardiology
Outcome results
None listed