Antiplatelet Effect
Conditions
Brief summary
The investigators sought to evaluate the influence of pantoprazole, indicated as less effective than other proton pump inhibitors, on the antiplatelet effect of clopidogrel, with stratification of the population according to the presence of cytochrome (CYP) 2C19 polymorphism.
Detailed description
Participants being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin daily after previous PCI with coronary stenting were included in the study. Participants were randomly assigned to either the pantoprazole 40 mg once-daily group or the ranitidine 150 mg twice-daily group using a computer-generated randomized table. An independent investigator generated the random allocation sequence. Blood samples were collected at 9:00 on day prior to treatment (day 0) and on day 9. Measuring impedance was performed by one independent investigator in a blinded manner.
Interventions
DRUGPantoprazole
pantoprazole 40 mg once-daily
DRUGRanitidine
ranitidine 150 mg twice-daily
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin daily after previous PCI with coronary stenting were included in the study. All patients received standardized therapy with a loading dose of 600 mg of clopidogrel hydrogen sulfate and 400 mg aspirin. All participants had a normal platelet count (150,000-450,000/mL).
Exclusion criteria
* Patients with severe liver disorders, current gastrointestinal disorders, a current infection, congestive heart failure, or a known bleeding disorder as well as patients on bivalirudin or glycoprotein IIb/III antagonists within the last 7 days were excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with more than 5 Ω of impedance after intervention by an aggregometer which measures platelet aggregation in whole blood samples | 8 days | 8 days after administration of pantoprazole (or ranitidine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the impedance value (Ω) by an aggregometer which measures platelet aggregation in whole blood samples | baseline and 8days | 8 days after administration of pantoprazole (or ranitidine) |
| Number of participants with gastrointestinal bleeding | up to 2weeks | — |
| Number of participants with reccured coronary artery disease | up to 2weeks | — |
Countries
South Korea
Outcome results
None listed