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Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

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ClinicalTrials.gov Identifier: NCT00683111
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
Fook-Hong Ng, Ruttonjee Hospital

Tracking Information
First Submitted Date  ICMJE May 21, 2008
First Posted Date  ICMJE May 23, 2008
Last Update Posted Date June 6, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2008)
ulcer complication (bleeding/perforation/obstruction) [ Time Frame: up to 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00683111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2008)
Termination of anti-ischemic drug due to ulcer complications; TIMI severity of GI bleeding; Major adverse cardiac event (composite of death from CV causes, recurrent nonfatal MI, or stroke); [ Time Frame: up to 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease
Official Title  ICMJE Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction
Brief Summary Aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and effective treatment for unstable cardiac patients. However, the major complication was gastrointestinal bleeding (GIB) due to peptic ulcer. In the prevention of GIB, anti-ulcer drug either H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) were commonly prescribed. There has been no prospective controlled study to compare the efficacy of these two classes of anti-ulcer drugs.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Coronary Syndrome
  • Acute Myocardial Infarction
Intervention  ICMJE
  • Drug: esomeprazole 20 mg daily
    oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
  • Drug: famotidine 40 mg daily
    oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
Study Arms  ICMJE
  • 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
Publications * Ng FH, Tunggal P, Chu WM, Lam KF, Li A, Chan K, Lau YK, Kng C, Keung KK, Kwan A, Wong BC. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol. 2012 Mar;107(3):389-96. doi: 10.1038/ajg.2011.385. Epub 2011 Nov 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 22, 2008)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients admitted for acute coronary syndrome or acute myocardial infarction requiring active treatment with aspirin clopidogrel and (enoxaparin or thrombolytics.)

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, enoxaparin 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
  • already on proton pump inhibitor for > 1 day or another clinical trial drug for ulcer disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00683111
Other Study ID Numbers  ICMJE HKEC-2007-176
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fook-Hong Ng, Ruttonjee Hospital
Study Sponsor  ICMJE Ruttonjee Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fook Hong Ng, MBBS Ruttonjee Hospital
PRS Account Ruttonjee Hospital
Verification Date June 2012

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