NCT00683111

Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Ruttonjee Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-05-23
• Last updated: 2012-06-06

Locations

1 site across 1 country: China