Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

Sponsor

Ruttonjee Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01062516

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators examine the influence of esomeprazole versus famotidine on antiplatelet action of clopidogrel associated with aspirin. At least 100 consecutive patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day or 75mg/day for at least 7 consecutive days), are randomised to receive either esomeprazole 20 mg daily vs famotidine 40 mg daily in a double blinded manner. Clopidogrel effect was tested by measuring residual platelet reactivity (RPR) to ADP by VerifyNow P2Y12 assay (Accumetrics Inc, San Diego, Calif). At baseline, whole blood will be obtained for RPR at least 12 h after clopidogrel loading dose or at least 7 days of maintaince dose. Immediately obtaining the baseline blood, patients will be randomized to receive either esomeprazole (20 mg/day) or famotidine 40 mg/day for 28 days. Double blinding will be performed by encapsulation of study drugs. RPR will be measured again at the 28th day.

The investigators will compare the % inhibition and the P2Y12 reaction Units (PRU) at the 28-day treatment period in the 2 groups.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Acute Myocardial Infarction	Drug: esomeprazole 20 mg daily Drug: famotidine 40 mg daily	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 oral esomeprazole 20 mg daily	Drug: esomeprazole 20 mg daily oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for 28 days
Active Comparator: 2 oral famotidine 40mg daily	Drug: famotidine 40 mg daily oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for 28 days

Arm

Intervention/Treatment

Active Comparator: 1

oral esomeprazole 20 mg daily

Drug: esomeprazole 20 mg daily

oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for 28 days

Active Comparator: 2

oral famotidine 40mg daily

Drug: famotidine 40 mg daily

oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for 28 days

Outcome Measures

Primary Outcome Measures

P2Y12 reaction units [28 days]

Secondary Outcome Measures

percent inhibition [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation (PCI) , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day), are recruited.