Clopidogrel Proton-Pump Inhibitors Study

NCT01016717 | Withdrawn Phase 4

• 1 other identifier: SHEBA-09-7345-MS-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

clopidogrel; platelet function; omeprazole; pantoprazole; coronary disease

Outcome Measures

Primary Outcomes (1)

• Platelet function tests.

  30 days

Study Arms (2)

Omeprazole

ACTIVE COMPARATOR

Patients will be taking omeprazole tablets 40 mg QD for 30 days

Drug: Omeprazole

Pantoprazole

ACTIVE COMPARATOR

Patients will be taking Pantoprazole tablets 40 mg QD for 30 days

Drug: Pantoprazole

Interventions

Omeprazole DRUG

All patients will be taking omeprazole (Losec, Abic Inc., Israel) tablets 40 mg QD for 30 days

Also known as: Losec

Omeprazole

Pantoprazole DRUG

Pantoprazole tablets (Controloc 40, 40 mg/day, Nycomed, Perrigo Inc., Israel). All patients will take pantoprazole tablets 40 mg QD for 30 days

Also known as: Controloc

Pantoprazole

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years; signed informed consent
• Outpatient CAD patients on aspirin tablets 100-325 mg daily and clopidogrel tablets 75 mg daily.
• Left ventricular (LV) systolic dysfunction ≥ 40% measured within the past 6 months.
• No changes in cardiac medications during 2 weeks prior to enrollment.

You may not qualify if:

• Presence of transplanted tissue or organ or LVAD
• AICD or CRT or CRTD patients.
• Acute MI, CABG, PCI within past 3 months.
• Congestive heart failure (CHF) ≥ NYHA 2.
• Ejection fraction \< 40% measured within the past 6 months.
• Malignancy.
• Active myocarditis, or cardiomyopathy.
• HIV infection or immunodeficiency state.
• Chronic viral infection.
• Acute systemic infection requiring antibiotics.
• Chronic diarrhea or malabsorption.
• Statin therapy initiation ≤ 3 months.
• Diabetes mellitus type 1.
• Diabetes mellitus type 2 with HbA1C \> 7%
• Low-density lipoprotein cholesterol (LDL-C) \> 100 mg/dL.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Leviev Heart Center, Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Interventions

Omeprazole; Pantoprazole

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michael Shechter, MD, MA

  Leviev Heart Center, Sheba Medical Center, Tel Hashomer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: December 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 21, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)