Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 28, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedApril 11, 2016
April 1, 2016
2.6 years
March 28, 2016
April 5, 2016
Conditions
Outcome Measures
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)
8 days
Secondary Outcomes (3)
Change of the impedance value (Ω) by an aggregometer which measures platelet aggregation in whole blood samples
baseline and 8days
Number of participants with gastrointestinal bleeding
up to 2weeks
Number of participants with reccured coronary artery disease
up to 2weeks
Study Arms (2)
Pantoprazole
ACTIVE COMPARATORDrug: Pantoprazole 40 mg once-daily
Ranitidine
EXPERIMENTALDrug: Ranitidine 150 mg twice-daily
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related Publications (1)
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.
PMID: 28395507DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI (professor)
Study Record Dates
First Submitted
March 28, 2016
First Posted
April 11, 2016
Study Start
October 1, 2012
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
April 11, 2016
Record last verified: 2016-04