Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683111
• Other study ID #: HKEC-2007-176
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2008
• Last updated: June 5, 2012
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: Ruttonjee Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• esomeprazole 20 mg daily
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
• famotidine 40 mg daily
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months

Locations

Country	Name	City	State
China	Ruttonjee Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Ruttonjee Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ulcer complication (bleeding/perforation/obstruction)		up to 12 months	Yes
Secondary	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	Yes