Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

This study has been completed.
Sponsor:
Information provided by:
Ruttonjee Hospital
ClinicalTrials.gov Identifier:
NCT01062516
First received: February 2, 2010
Last updated: October 2, 2010
Last verified: October 2010
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • percent inhibition [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01062516

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

No publications provided by Ruttonjee Hospital

Additional 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
Study First Received: February 2, 2010
Last Updated: October 2, 2010
Health Authority: Hong Kong: Ethics Committee

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
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Aspirin
Clopidogrel
Esomeprazole
Famotidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on July 31, 2014