Clinical trial NCT02418312: Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer
Official title: Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peptic Ulcer
Keywords: histamine-2 receptor antagonist
peptic ulcer
thienopyridine
prevention
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 228
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains unclear.

Detailed description: The aim of the prospective, randomized study is investigate the efficacy of H2 receptor antagonist in prevention of thienopyridine-related peptic ulcer and gastrointestinal bleeding in patients with an ulcer history. We plan to enroll 236 thienopyridine (clopidogrel or ticlopidine) users with a peptic ulcer history who don't have baseline gastroduodenal ulcers at initial endoscopy . The patients will be randomly assigned to receive either (1) famotidine (40 mg qd) plus thienopyridine used previously or (2) placebo plus thienopyridine treatment alone for 6 months. The ulcer recurrence rate between the treatment gruops will be compared.

Eligibility criteria: Inclusion Criteria:

1. The past history of gastroduodenal ulcer and underwent endoscopy for dyspeptic symptoms.
2. thienopyridine users without baseline gastroduodenal ulcer at initial endoscopy.
3. They are adult patients aged least 20 years of age.

Exclusion Criteria:

1. They have a history of gastric or duodenal surgery other than oversewing of a perforation.
2. They require long-term treatment with non-steroidal anti-inflammatory drugs.
3. serious disease.

Primary outcomes:
measure: Number of Participants With Healed Peptic Ulcer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Ping-I Hsu, Bachelor
role: STUDY_CHAIR
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