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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

February 2, 2010
October 2, 2010
January 2010
September 2010   (final data collection date for primary outcome measure)
P2Y12 reaction units [ Time Frame: 28 days ] [ Designated as safety issue: No ]
degree of patient inhibition as defined by the percent inhibition - calculated as [(1 − PRU/BASE) × 100]. P2Y12 reaction units (PRU) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01062516 on ClinicalTrials.gov Archive Site
percent inhibition [ Time Frame: 28 days ] [ Designated as safety issue: No ]
platelet inhibition as defined by P2Y12 reaction Units (PRU) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin
Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Acute Coronary Syndrome
  • Acute Myocardial Infarction
  • 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
  • Active Comparator: 1
    oral esomeprazole 20 mg daily
    Intervention: Drug: esomeprazole 20 mg daily
  • Active Comparator: 2
    oral famotidine 40mg daily
    Intervention: Drug: famotidine 40 mg daily
Tunggal P, Ng FH, Lam KF, Chan FK, Lau YK. Effect of esomeprazole versus famotidine on platelet inhibition by clopidogrel: a double-blind, randomized trial. Am Heart J. 2011 Nov;162(5):870-4. doi: 10.1016/j.ahj.2011.08.007. PubMed PMID: 22093203.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01062516
HKEC 2007-176 VerifyNow
Yes
Dr Fook Hong Ng, Ruttonjee Hospital
Ruttonjee Hospital
Not Provided
Principal Investigator: Fook Hong Ng, MBBS Ruttonjee Hospital
Ruttonjee Hospital
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP