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Prevention of Gastrointestinal Bleeding in Patients With Severe Ischemic Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fook-Hong Ng, Ruttonjee Hospital
ClinicalTrials.gov Identifier:
NCT00683111
First received: May 21, 2008
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Acute Myocardial Infarction
 Drug: esomeprazole 20 mg daily
Drug: famotidine 40 mg daily
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ruttonjee Hospital:

Primary Outcome Measures:
  • ulcer complication (bleeding/perforation/obstruction) [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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); [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: July 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
oral esomeprazole 20 mg daily
 Drug: esomeprazole 20 mg daily
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months
Active Comparator: 2
oral famotidine 40mg daily
 Drug: famotidine 40 mg daily
oral famotidine 40 mg daily vs. oral esomeprazole 20 mg daily for up to 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683111

Locations
China
Ruttonjee Hospital
Hong Kong, China
Sponsors and Collaborators
Ruttonjee Hospital
Investigators
Principal Investigator: Fook Hong Ng, MBBS Ruttonjee Hospital
  More Information

No publications provided

Responsible Party: Fook-Hong Ng, SMO, Ruttonjee Hospital
ClinicalTrials.gov Identifier: NCT00683111     History of Changes
Other Study ID Numbers: HKEC-2007-176
Study First Received: May 21, 2008
Last Updated: June 5, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Ruttonjee Hospital:
acute coronary syndrome
acute myocardial infarction
aspirin
clopidogrel
 heparin
thrombolytic
famotidine
esomeprazole

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Gastrointestinal Hemorrhage
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
 Pathologic Processes
Ischemia
Necrosis
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Famotidine
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists

ClinicalTrials.gov processed this record on May 23, 2013