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Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01138969
First received: June 7, 2010
Last updated: February 2, 2013
Last verified: February 2013
History of Changes
  Purpose

Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.


Condition Intervention Phase
Peptic Ulcer
 Drug: esomeprazole
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer and Gastrointestinal Bleeding

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Recurrent Peptic Ulcer [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of participants with recurrent peptic ulcer within 6 months


Secondary Outcome Measures:
  • Peptic Ulcer Bleeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    participants with peptic ulcer bleeding within 6 months


Enrollment: 165
Study Start Date: August 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Esomeprazole plus clopidogrel group
esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
 Drug: esomeprazole
esomeprazole 20 mg qd for 6 months
Other Name: plavix
No Intervention: Clopidogrel group
clopidogrel 75 mg qd for 6 months

Detailed Description:

The aim of the prospective, randomized study is to investigate the efficacy of PPI in prevention of ulcer recurrence for clopidogrel users. We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months. The ulcer recurrence rate between the treatment groups will be compared.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.

Exclusion Criteria:

  • 1.serious disease 2.refuse informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138969

Locations
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Study Chair: Kwok-Hung Lai, MD Kaohsiung Veterans General Hospital.
  More Information

No publications provided by Kaohsiung Veterans General Hospital.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ping-I (William) Hsu, M.D., Chief, Gastroenterology Division, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01138969     History of Changes
Other Study ID Numbers: VGHKS98-CT6-12
Study First Received: June 7, 2010
Results First Received: December 31, 2012
Last Updated: February 2, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
proton pump inhibitor
peptic ulcer
clopidogrel
prevention

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Peptic Ulcer
Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Omeprazole
Clopidogrel
Proton Pump Inhibitors
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Hematologic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013