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Acute Coronary Syndromes | Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Trials(OPEN)

Acute Coronary Syndromes research study

What is the primary objective of this study?

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 .

Who is eligible to participate?

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;

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Coronary Syndromes

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:omeprazoleall 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:PantoprazoleOn 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

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

omeprazole groupomeprazole 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) .

pantoprazole grouppantoprazole 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).

Study Status

Unknown status

Start Date: November 2012

Completed Date: October 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Platelet aggregation rate(AA 、ADP)

Secondary Outcome: clinical adverse events

Study sponsors, principal investigator, and references

Principal Investigator: Han Yaling, MD

Lead Sponsor: Yaling Han

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01735227

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