Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Peptic Ulcer

Treatments: Drug: Placebo; Drug: histamine-2 receptor antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT02418312

VGHKS11-CT12-10

Details and patient eligibility

About

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

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 2 patient groups, including a placebo group

histamine-2 receptor antagonist group

Active Comparator group

Description:

famotidine 40mg qd for 6 months.

Treatment:

Drug: histamine-2 receptor antagonist

placebo group

Placebo Comparator group

Description:

placebo for 6 months.

Treatment:

Drug: Placebo