Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Trials(OPEN)
Information source: Shenyang Northern Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndromes
Intervention: omeprazole (Drug); Pantoprazole (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Yaling Han Official(s) and/or principal investigator(s): Han Yaling, MD, Principal Investigator, Affiliation: Shenyang Northern Hospital
Overall contact: Han Yaling, MD, Phone: +86-024-28897309, Email: lijing790126@sina.com
Summary
In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect
, the investigators designed a clinical randomized controlled trials of omeprazole and
pantoprazole antiplatelet effect of clopidogrel .In this experiment , the investigators have
taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly
divided into omeprazole and pantoprazole groups . On the day of admission , all patients
taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of
clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d ,
pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission (
before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days ,
each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet
aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical
adverse events ( including death , myocardial infarction , and any revascularization , stent
thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding
events) . To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1
year follow-up results , and further explore the optimal combination of dual anti-platelet
and joint PPIs course of treatment , appropriate dosage and the best time to provide
reasonable for clinical programs to create a personalized treatment system , improve the
patient's quality of life .
Clinical Details
Official title: Single-center Randomized Controlled Study of Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Randomized Controlled Trials
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Platelet aggregation rate(AA 、ADP)
Secondary outcome: clinical adverse events
Detailed description:
Through a number of large-scale clinical trials , Meta analysis, and clinical treatment
guidelines confirm that clopidogrel and aspirin dual antiplatelet treatment strategies for
acute coronary syndrome (ACS) undergoing percutaneous coronary interventions(PCI) of stent
implantation surgery patients have a vital role . It can effectively suppress acute
、subacute stent thrombosis formation , reduce readmissions ratio , thus greatly improving
the quality of life of patients . A large number of clinical practice reports, although the
treatment strategies to reduce the incidence of adverse cardiovascular events ,it has
increased the possibility of the occurrence of gastrointestinal bleeding complications .
Proton pump inhibitors (PPIs) are often used to prevent gastrointestinal complications of
dual antiplatelet therapy . 2008 American College of Cardiology (ACC) / American Society of
Gastroenterology (ACG) / American Heart Association (AHA) jointly issued a consensus
document , consistently recommended that the majority of clinicians application of dual
antiplatelet and PPIs treatment for patients with risk factors for gastrointestinal bleeding
that may exist at the same time ,in order to reduce the occurrence of gastrointestinal
adverse events . But at home and abroad in recent years, there have been reports suggest
that the interaction of PPIs with clopidogrel may exist , thereby reduce the latter 's anti-
platelet effect , in order to make the incidence of adverse CV events increased about 25-64
% . In January 2009 , the U. S. Food and Drug Administration (FDA) announced a safety review
of an earlier report on the potential interaction of these two types drugs , particularly
stressed the need to carry out a large number of clinical practice research further to clear
both the interaction . PPIs antiplatelet effects of clopidogrel after PCI is not yet very
clear , clinical results on both interactions still exist many different academic
perspectives and research defects , so still need to arouse sufficient attention , continue
to carry out the relevant fields research .
In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect
, the investigators designed a clinical randomized controlled trials of omeprazole and
pantoprazole antiplatelet effect of clopidogrel .In this experiment , the investigator have
taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly
divided into omeprazole and pantoprazole groups . On the day of admission , all patients
taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of
clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d ,
pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission (
before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days ,
each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet
aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical
adverse events ( including death , myocardial infarction , and any revascularization , stent
thrombosis , recurrent angina , rehospitalization due to cardiovascular disease , bleeding
events) . To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1
year follow-up results , and further explore the optimal combination of dual anti-platelet
and joint PPIs course of treatment , appropriate dosage and the best time to provide
reasonable for clinical programs to create a personalized treatment system , improve the
patient's quality of life .
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. ACS (including unstable angina pectoris, non-ST-segment elevation myocardial
infarction and ST-elevation myocardial infarction) ;
2. The age between18 and 75 ;
3. Informed consent.
Exclusion Criteria:
1. Receiving GP IIb / IIIa receptor antagonist treatment;
2. Had received prior to enrollment 7d cilostazol;
3. Dual antiplatelet therapy contraindications;
4. NYHA grade III ~ IV;
5. Presence of multivessel severe coronary lesions , need elective coronary
revascularization;
6. The need for long-term use of warfarin after valve surgery or persistent atrial
fibrillation;
7. Severe liver or kidney dysfunction;
8. Has not been cured of peptic ulcer or presence of bleeding tendency;
9. Who complicate the known bleeding tendency and blood system diseases;
10. Have a history of intracranial hemorrhage within 6 monhs;
11. Planned surgery recently;
12. Pregnancy;
13. Other serious illness, life expectancy less than 6 months;
14. Nearly 1 year underwent PCI , regular take aspirin 、clopidogrel since;
Locations and Contacts
Han Yaling, MD, Phone: +86-024-28897309, Email: lijing790126@sina.com
OPEN trail, Shenyang, Liaoning 110016, China; Not yet recruiting Han Yaling, MD, Phone: +86-24-28897309, Email: lijing790126@sina.com
ShenyangNH, Shenyang, Liaoning 110016, China; Not yet recruiting Han Yaling MD, Phone: +86-24-23922184, Email: hanyaling@263.net
Additional Information
Starting date: November 2012
Last updated: November 27, 2012
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