Coronary Artery Disease Clinical Trial
Official title:
Clopidogrel Proton-Pump Inhibitors Study
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Leviev Heart Center, Sheba Medical Center | Tel Hashomer |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Platelet function tests. | 30 days | No |
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