Back to resultsPrevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease
Primary Purpose
Acute Coronary Syndrome, Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
esomeprazole 20 mg daily
famotidine 40 mg daily
Sponsored by
About this trial
This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, acute myocardial infarction, aspirin, clopidogrel, heparin, thrombolytic, famotidine, esomeprazole
Eligibility Criteria
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
Sites / Locations
- Ruttonjee Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
oral esomeprazole 20 mg daily
oral famotidine 40mg daily
Outcomes
Primary Outcome Measures
ulcer complication (bleeding/perforation/obstruction)
Secondary Outcome Measures
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);
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00683111
Brief Title
Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease
Official Title
Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruttonjee Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Acute Myocardial Infarction
Keywords
acute coronary syndrome, acute myocardial infarction, aspirin, clopidogrel, heparin, thrombolytic, famotidine, esomeprazole
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
oral esomeprazole 20 mg daily
Arm Title
2
Arm Type
Active Comparator
Arm Description
oral famotidine 40mg daily
Intervention Type
Drug
Intervention Name(s)
esomeprazole 20 mg daily
Intervention Description
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
Intervention Type
Drug
Intervention Name(s)
famotidine 40 mg daily
Intervention Description
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
Primary Outcome Measure Information:
Title
ulcer complication (bleeding/perforation/obstruction)
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fook Hong Ng, MBBS
Organizational Affiliation
Ruttonjee Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruttonjee Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22108447
Citation
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.
Results Reference
derived
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Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease
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