Clopidogrel Proton-Pump Inhibitors Study

• Status: Withdrawn
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To find out the impact of two different proton-pump inhibitors (PPIs) (Omeprazole and Pantoprazole) on platelet function in patients with stable coronary artery disease (CAD) on clopidogrel therapy.

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

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Clopidogrel; Omeprazole; Pantoprazole; Proton Pump Inhibitors

Criteria

Inclusion criteria:

1. Male or female ≥ 18 years; signed informed consent

2. Outpatient CAD patients on aspirin tablets 100-325 mg daily and clopidogrel tablets 75 mg daily.

3. Left ventricular (LV) systolic dysfunction ≥ 40% measured within the past 6 months.

4. No changes in cardiac medications during 2 weeks prior to enrollment.

Exclusion criteria:

1. Presence of transplanted tissue or organ or LVAD

2. AICD or CRT or CRTD patients.

3. Acute MI, CABG, PCI within past 3 months.

4. Congestive heart failure (CHF) ≥ NYHA 2.

5. Ejection fraction < 40% measured within the past 6 months.

6. Malignancy.

7. Active myocarditis, or cardiomyopathy.

8. HIV infection or immunodeficiency state.

9. Chronic viral infection.

10. Acute systemic infection requiring antibiotics.

11. Chronic diarrhea or malabsorption.

12. Statin therapy initiation ≤ 3 months.

13. Diabetes mellitus type 1.

14. Diabetes mellitus type 2 with HbA1C > 7%

15. Low-density lipoprotein cholesterol (LDL-C) > 100 mg/dL.

16. Not on statin therapy.

17. Liver function tests (LFT) ≥ x 3 upper limit of normal (ULN) or creatinine kinase (CPK) ≥ x 10 ULN.

18. Hypo/hyper thyroidism.

19. Liver dysfunction.

20. Renal failure with serum creatinine ≥ 2 mg/dL.

21. Alcohol or drug abuse.

22. Refuse to sign informed consent.

23. On the following therapy: Amiodarone, coumadin, any antibiotics.