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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Shenyang Northern Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Yaling Han, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01735227
First received: November 14, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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 .


Condition Intervention Phase
Acute Coronary Syndromes
Drug: omeprazole
Drug: Pantoprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Single-center Randomized Controlled Study of Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Randomized Controlled Trials

Resource links provided by NLM:


Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • Platelet aggregation rate(AA 、ADP) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    1. MACE(including cardiac death, acute myocardial infarction , target lesion revascularization , shock);
    2. stent thrombosis;
    3. stroke


Estimated Enrollment: 620
Study Start Date: November 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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) .
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
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).
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735227

Contacts
Contact: Han Yaling, MD +86-024-28897309 lijing790126@sina.com

Locations
China, Liaoning
OPEN trail Not yet recruiting
Shenyang, Liaoning, China, 110016
Contact: Han Yaling, MD    +86-24-28897309    lijing790126@sina.com   
ShenyangNH Not yet recruiting
Shenyang, Liaoning, China, 110016
Contact: Han Yaling MD    +86-24-23922184    hanyaling@263.net   
Sponsors and Collaborators
Yaling Han
Investigators
Principal Investigator: Han Yaling, MD Shenyang Northern Hospital
  More Information

No publications provided

Responsible Party: Yaling Han, vice president, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01735227     History of Changes
Other Study ID Numbers: NH2012-9-20
Study First Received: November 14, 2012
Last Updated: November 27, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shenyang Northern Hospital:
pantoprazole
omeprazole
anti - platelet effect

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Clopidogrel
Omeprazole
Pantoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Proton Pump Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014