Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?

Not Applicable

Completed

• Conditions: Antiplatelet Effect
• Interventions: Drug: Pantoprazole; Drug: Ranitidine

• Registration Number: NCT02733640
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2016-03-28
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-05
• Last Update Submitted: 2016-04-05
• Study First Posted: 2016-04-11
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pantoprazole	Pantoprazole	Drug: Pantoprazole 40 mg once-daily
Ranitidine	Ranitidine	Drug: Ranitidine 150 mg twice-daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants with gastrointestinal bleeding	up to 2weeks
Number of participants with reccured coronary artery disease	up to 2weeks
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)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of