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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pantoprazole | Active Comparator | Drug: Pantoprazole 40 mg once-daily |
|
| Ranitidine | Experimental | Drug: Ranitidine 150 mg twice-daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | pantoprazole 40 mg once-daily |
| |
| Ranitidine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 after administration of pantoprazole (or ranitidine) | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the impedance value (Ω) by an aggregometer which measures platelet aggregation in whole blood samples | 8 days after administration of pantoprazole (or ranitidine) | baseline and 8days |
| Number of participants with gastrointestinal bleeding |
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Inclusion Criteria:
All participants had a normal platelet count (150,000-450,000/mL).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28395507 | Derived | Choi YJ, Kim N, Jang IJ, Cho JY, Nam RH, Park JH, Jo HJ, Yoon H, Shin CM, Park YS, Lee DH, Jung HC. Pantoprazole Does Not Reduce the Antiplatelet Effect of Clopidogrel: A Randomized Controlled Trial in Korea. Gut Liver. 2017 Jul 15;11(4):504-511. doi: 10.5009/gnl16352. |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| D011899 | Ranitidine |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
ranitidine 150 mg twice-daily |
|
| up to 2weeks |
| Number of participants with reccured coronary artery disease | up to 2weeks |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005663 | Furans |