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OpenTrials
Completed

NCT Number: NCT02733640

Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?

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.

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Key information

Conditions

Antiplatelet Effect

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pantoprazole

Drug

pantoprazole 40 mg once-daily

Ranitidine

Drug

ranitidine 150 mg twice-daily

Primary outcomes

  1. Number of participants with more than 5 Ω of impedance after intervention by an aggregometer which measures platelet aggregation in whole blood samples

    Time frame: 8 days

    8 days after administration of pantoprazole (or ranitidine)

Secondary outcomes

  1. Change of the impedance value (Ω) by an aggregometer which measures platelet aggregation in whole blood samples

    Time frame: baseline and 8days

    8 days after administration of pantoprazole (or ranitidine)

  2. Number of participants with gastrointestinal bleeding

    Time frame: up to 2weeks

  3. Number of participants with reccured coronary artery disease

    Time frame: up to 2weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 11, 2016
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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