Thai patients with diabetic mellitus and coronary artery disease Clopidogrel, Coronary artery disease, Diabetes mellitus, Omeprazole, Platelet reactivity, VerifyNow
Conditions
Interventions
Study drugs were administered 30 minutes before meals, with other medications taken subsequently
-omeprazole 20 mg once daily for two weeks, followed by crossover to the alternate treatment as placebo
Active Comparator Drug,Placebo Comparator Drug
Omeprazole 20 mg,Identical placebo
Sponsors
Royal College of Physicians of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. diagnosis of ACS or CCS who had undergone prior revascularisation, either by coronary artery bypass grafting or percutaneous coronary intervention, at least two weeks before screening. 2. Patients were required to have been receiving aspirin 81 mg/day and clopidogrel 75 mg/day for more than two weeks without omeprazole 3. Confirmed diagnosis of DM according to standard clinical criteria.
Exclusion criteria
Exclusion criteria: 1. Patients with an indication for any acid-suppressive or gastroprotective medication, including proton pump inhibitors (PPIs), H2 receptor antagonists, sucralfate, or misoprostol. 2. Patients diagnosed with esophageal ulcer, gastric ulcer, esophageal or gastrointestinal varices, or gastroesophageal reflux disease (GERD). 3. Patients with Helicobacter pylori infection within the past 2 months. 4. Patients receiving oral anticoagulants 5. Patients who have received thrombolytic therapy within 48 hours prior to screening. 6.History of heart failure, New York Heart Association (NYHA) Class III anIV. History of Type 2 myocardial infarction (MI). 7. Patients diagnosed with liver cirrhosis. 8. Patients who are planned to receive or are currently receiving immunosuppressive therapy. 9.Patients who are planned to receive or are currently receiving systemic corticosteroids, including oral or intravenous formulations. 10. Patients who regularly use nonsteroidal anti-inflammatory drugs (NSAIDs) and are unable to discontinue them. 11.Patients with a history of bleeding disorders, whether congenital or acquired. 12. Patients with active bleeding or a history of internal bleeding, including gastrointestinal bleeding, intracranial hemorrhage, or bleeding within the cranial cavity and meninges. 13. Patients currently receiving strong cytochrome P450 CYP3A4 inhibitors (drug interaction concern). 14. Patients with a history of allergy or contraindication to any acid-suppressive/gastroprotective medication (PPIs, H2 receptor antagonists, sucralfate, or misoprostol), as well as clopidogrel or aspirin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Within-participant difference in change in P2Y12 reaction units between omeprazole and placebo periods Baseline and week 2 of each crossover period (total 4 weeks) Platelet reactivity measured as P2Y12 reaction units, or PRU, using a platelet function test. PRU will be measured at the beginning, crossover at week 2 and end of study at week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Within-participant difference in change in clopidogrel responder status between omeprazole and placebo periods Baseline and week 2 of each crossover period (total 4 weeks) Clopidogrel responder status based on platelet reactivity measured by PRU. Participants will be classified as clopidogrel responders or non-responders according to a pre-specified PRU threshold. | — |
Countries
Thailand
Contacts
Public ContactMetus Thungthienthong
Ramathibodi Hospital, Mahidol University
Outcome results
None listed