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Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062516
First Posted: February 4, 2010
Last Update Posted: October 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ruttonjee Hospital
  Purpose

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 Intervention Phase
Acute Coronary Syndrome Acute Myocardial Infarction Drug: esomeprazole 20 mg daily Drug: famotidine 40 mg daily Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ruttonjee Hospital:

Primary Outcome Measures:
  • P2Y12 reaction units [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • percent inhibition [ Time Frame: 28 days ]

Estimated Enrollment: 100
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • known active peptic ulcer disease or gastrointestinal within 8 wk
  • known iron deficiency anemia with Hb < 10 gm/dl
  • mechanical ventilation
  • active cancer, liver cirrhosis, end-stage renal failure
  • life expectancy < 1 yr
  • known allergic to aspirin, clopidogrel, famotidine or esomeprazole
  • pregnancy, lactation, child-bearing potential in the absence of contraception,
  • co-prescription of NSAID, corticosteroid, or warfarin
  • non-oral feeding or impaired GI absorption e.g. vomiting
  • patient on proton pump inhibitor within 4 weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062516


Locations
China
Ruttonjee Hospital
Hong Kong, China
Sponsors and Collaborators
Ruttonjee Hospital
Investigators
Principal Investigator: Fook Hong Ng, MBBS Ruttonjee Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Fook Hong Ng, Ruttonjee Hospital
ClinicalTrials.gov Identifier: NCT01062516     History of Changes
Other Study ID Numbers: HKEC 2007-176 VerifyNow
First Submitted: February 2, 2010
First Posted: February 4, 2010
Last Update Posted: October 5, 2010
Last Verified: October 2010

Keywords provided by Ruttonjee Hospital:
acute coronary syndrome
acute myocardial infarction
percutaneous coronary intervention
aspirin
clopidogrel
esomeprazole
famotidine
platelet function

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Clopidogrel
Esomeprazole
Famotidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists