Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?

Antiplatelet Effect Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733640
• Other study ID #: B-1112/141-006
• Status: Completed
• Phase: N/A
• First received: March 28, 2016
• Last updated: April 5, 2016
• Start date: October 2012
• Est. completion date: May 2015

Study information

• Verified date: April 2016
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institutional Review Board: Korea
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Antiplatelet Effect

Intervention

Drug:
• Pantoprazole
pantoprazole 40 mg once-daily
• Ranitidine
ranitidine 150 mg twice-daily

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with more than 5 ? 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	No
Secondary	Change of the impedance value (?) by an aggregometer which measures platelet aggregation in whole blood samples	8 days after administration of pantoprazole (or ranitidine)	baseline and 8days	No
Secondary	Number of participants with gastrointestinal bleeding		up to 2weeks	Yes
Secondary	Number of participants with reccured coronary artery disease		up to 2weeks	Yes