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CompletedNCT02733640Updated Apr 11, 2016

Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?

An interventional study of Pantoprazole and Ranitidine in Antiplatelet Effect, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-04-11.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Antiplatelet Effect
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In context

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Pantoprazole

    Drug: Pantoprazole 40 mg once-daily

    Drug: Pantoprazole

  • Experimental
    Ranitidine

    Drug: Ranitidine 150 mg twice-daily

    Drug: Ranitidine

Interventions

  • DrugPantoprazole

    pantoprazole 40 mg once-daily

  • DrugRanitidine

    ranitidine 150 mg twice-daily

06

What researchers measure

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

    8 days after administration of pantoprazole (or ranitidine)

    Time frame: 8 days

Secondary outcomes

  1. 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)

    Time frame: baseline and 8days

  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

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Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 463-707, Korea, Republic of
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References and documents

Publications

  • 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. PubMed 28395507 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02733640
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Nayoung Kim (PI (professor), Seoul National University Bundang Hospital) — Principal investigator
First posted
Apr 11, 2016
Start date
Oct 2012
Primary completion
May 2015
Completion
May 2015
Last update
Apr 11, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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