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Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

NCT00683111 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2012-06-06

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome
  • Acute Myocardial Infarction

Interventions

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

Sponsors & Collaborators

  • Ruttonjee Hospital

    lead OTHER

Principal Investigators

  • Fook Hong Ng, MBBS · Ruttonjee Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00683111 on ClinicalTrials.gov