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Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

NCT01062516 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-10-05

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome
  • Acute Myocardial Infarction

Interventions

DRUG

esomeprazole 20 mg daily

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

DRUG

famotidine 40 mg daily

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

Sponsors & Collaborators

  • Ruttonjee Hospital

    lead OTHER

Principal Investigators

  • Fook Hong Ng, MBBS · Ruttonjee Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01062516 on ClinicalTrials.gov