Influence of omeprazole and famotidine on the antiplatelet effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes: A multicenter, randomized prospective study.

Not Applicable

• Conditions: Acute Coronary Syndromes

• Registration Number: JPRN-UMIN000002939
• 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: 2011-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)