Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

Phase 4

Completed

• Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction
• Interventions: Drug: famotidine 40 mg daily; Drug: esomeprazole 20 mg daily

• Registration Number: NCT00683111
• Lead Sponsor: Ruttonjee Hospital

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 available

Study Timeline

• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Study Start: 2008-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	famotidine 40 mg daily	oral famotidine 40mg daily
1	esomeprazole 20 mg daily	oral esomeprazole 20 mg daily

Primary Outcome Measures

Name	Time	Method
ulcer complication (bleeding/perforation/obstruction)	up to 12 months

Secondary Outcome Measures

Name	Time	Method
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);	up to 12 months

Trial Locations

Locations (1)

Ruttonjee Hospital; 🇨🇳 Hong Kong, China