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

• Status: Unknown status
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yaling Han
• Treatments: Aspirin; Clopidogrel; Omeprazole; Pantoprazole; Ticlopidine

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;