Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin
Primary Purpose
Acute Coronary Syndrome, Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
esomeprazole 20 mg daily
famotidine 40 mg daily
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, acute myocardial infarction, percutaneous coronary intervention, aspirin, clopidogrel, esomeprazole, famotidine, platelet function
Eligibility Criteria
Inclusion Criteria:
- patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation (PCI) , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day), are recruited.
Exclusion Criteria:
- known active peptic ulcer disease or gastrointestinal within 8 wk
- known iron deficiency anemia with Hb < 10 gm/dl
- mechanical ventilation
- active cancer, liver cirrhosis, end-stage renal failure
- life expectancy < 1 yr
- known allergic to aspirin, clopidogrel, famotidine or esomeprazole
- pregnancy, lactation, child-bearing potential in the absence of contraception,
- co-prescription of NSAID, corticosteroid, or warfarin
- non-oral feeding or impaired GI absorption e.g. vomiting
- patient on proton pump inhibitor within 4 weeks
Sites / Locations
- Ruttonjee Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
oral esomeprazole 20 mg daily
oral famotidine 40mg daily
Outcomes
Primary Outcome Measures
P2Y12 reaction units
Secondary Outcome Measures
percent inhibition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01062516
Brief Title
Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin
Official Title
Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ruttonjee Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators examine the influence of esomeprazole versus famotidine on antiplatelet action of clopidogrel associated with aspirin. At least 100 consecutive patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day or 75mg/day for at least 7 consecutive days), are randomised to receive either esomeprazole 20 mg daily vs famotidine 40 mg daily in a double blinded manner. Clopidogrel effect was tested by measuring residual platelet reactivity (RPR) to ADP by VerifyNow P2Y12 assay (Accumetrics Inc, San Diego, Calif). At baseline, whole blood will be obtained for RPR at least 12 h after clopidogrel loading dose or at least 7 days of maintaince dose. Immediately obtaining the baseline blood, patients will be randomized to receive either esomeprazole (20 mg/day) or famotidine 40 mg/day for 28 days. Double blinding will be performed by encapsulation of study drugs. RPR will be measured again at the 28th day.
The investigators will compare the % inhibition and the P2Y12 reaction Units (PRU) at the 28-day treatment period in the 2 groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Acute Myocardial Infarction
Keywords
acute coronary syndrome, acute myocardial infarction, percutaneous coronary intervention, aspirin, clopidogrel, esomeprazole, famotidine, platelet function
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
oral esomeprazole 20 mg daily
Arm Title
2
Arm Type
Active Comparator
Arm Description
oral famotidine 40mg daily
Intervention Type
Drug
Intervention Name(s)
esomeprazole 20 mg daily
Intervention Description
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for 28 days
Intervention Type
Drug
Intervention Name(s)
famotidine 40 mg daily
Intervention Description
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for 28 days
Primary Outcome Measure Information:
Title
P2Y12 reaction units
Time Frame
28 days
Secondary Outcome Measure Information:
Title
percent inhibition
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation (PCI) , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day), are recruited.
Exclusion Criteria:
known active peptic ulcer disease or gastrointestinal within 8 wk
known iron deficiency anemia with Hb < 10 gm/dl
mechanical ventilation
active cancer, liver cirrhosis, end-stage renal failure
life expectancy < 1 yr
known allergic to aspirin, clopidogrel, famotidine or esomeprazole
pregnancy, lactation, child-bearing potential in the absence of contraception,
co-prescription of NSAID, corticosteroid, or warfarin
non-oral feeding or impaired GI absorption e.g. vomiting
patient on proton pump inhibitor within 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fook Hong Ng, MBBS
Organizational Affiliation
Ruttonjee Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruttonjee Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22093203
Citation
Tunggal P, Ng FH, Lam KF, Chan FK, Lau YK. Effect of esomeprazole versus famotidine on platelet inhibition by clopidogrel: a double-blind, randomized trial. Am Heart J. 2011 Nov;162(5):870-4. doi: 10.1016/j.ahj.2011.08.007.
Results Reference
derived
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Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin
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