Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

NCT00683111 | Completed Phase 4 DMC

• 1 other identifier: HKEC-2007-176
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Acute Myocardial Infarction

Keywords

acute coronary syndrome; acute myocardial infarction; aspirin; clopidogrel; heparin; thrombolytic; famotidine; esomeprazole

Outcome Measures

Primary Outcomes (1)

• ulcer complication (bleeding/perforation/obstruction)

  up to 12 months

Secondary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

oral esomeprazole 20 mg daily

Drug: esomeprazole 20 mg daily

2

ACTIVE COMPARATOR

oral famotidine 40mg daily

Drug: famotidine 40 mg daily

Interventions

esomeprazole 20 mg daily DRUG

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

1

famotidine 40 mg daily DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruttonjee Hospital: lead

Study Sites (1)

Ruttonjee Hospital

Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 22108447 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Esomeprazole; Famotidine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

Study Officials

• Fook Hong Ng, MBBS

  Ruttonjee Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SMO

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

CN (1)