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Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?

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Seoul National University

Status

Completed

Conditions

Antiplatelet Effect

Treatments

Drug: Pantoprazole
Drug: Ranitidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02733640
B-1112/141-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

42 participants in 2 patient groups

Pantoprazole
Active Comparator group
Description:
Drug: Pantoprazole 40 mg once-daily
Treatment:
Drug: Pantoprazole
Ranitidine
Experimental group
Description:
Drug: Ranitidine 150 mg twice-daily
Treatment:
Drug: Ranitidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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