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Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Trials(OPEN)

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ClinicalTrials.gov Identifier: NCT01735227
Recruitment Status : Unknown
Verified November 2012 by Yaling Han, Shenyang Northern Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 28, 2012
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Yaling Han, Shenyang Northern Hospital

Tracking Information
First Submitted Date  ICMJE November 14, 2012
First Posted Date  ICMJE November 28, 2012
Last Update Posted Date November 28, 2012
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
Platelet aggregation rate(AA 、ADP) [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
clinical adverse events [ Time Frame: 12 months ]
  1. MACE(including cardiac death, acute myocardial infarction , target lesion revascularization , shock);
  2. stent thrombosis;
  3. stroke
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Trials(OPEN)
Official Title  ICMJE Single-center Randomized Controlled Study of Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Randomized Controlled Trials
Brief 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 .
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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Coronary Syndromes
Intervention  ICMJE
  • Drug: omeprazole
    all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term)and omeprazole group taking omeprazole 20mg/d
  • Drug: Pantoprazole
    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
Study Arms  ICMJE
  • Experimental: omeprazole group
    omeprazole group:all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term)and taking omeprazole 20mg/d(1 month).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) .
    Interventions:
    • Drug: omeprazole
    • Drug: Pantoprazole
  • Experimental: pantoprazole group
    pantoprazole group: all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term),taking pantoprazole 20mg/d(1 month).
    Interventions:
    • Drug: omeprazole
    • Drug: Pantoprazole
Publications * Gu RX, Wang XZ, Li J, Deng J, Li XX, Wang J. Effects of omeprazole or pantoprazole on platelet function in non-ST-segment elevation acute coronary syndrome patients receiving clopidogrel. Mil Med Res. 2016 Dec 15;3:38. doi: 10.1186/s40779-016-0107-0. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 27, 2012)
620
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01735227
Other Study ID Numbers  ICMJE NH2012-9-20
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yaling Han, Shenyang Northern Hospital
Study Sponsor  ICMJE Yaling Han
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Han Yaling, MD Shenyang Northern Hospital
PRS Account Shenyang Northern Hospital
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP