Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

King Chulalongkorn Memorial Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Gastric Ulcer Induced by Anti-platelet Agent; Duodenal Ulcer Induced by Anti-platelet Agent

Treatments: Drug: Repamipide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02166008

RP006

Details and patient eligibility

About

• Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents

• Study Design: Single center, double-blind, randomized-control trial study

• Study drug: Repamipide vs. placebo

• Assessment criteria The patients will be discharged from the study when one of the followings occurred,

  1. Peptic ulcer from upper endoscopy at 3 and 6 month follow up
  2. Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy
  3. Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy
  4. Evidence of recurrent myocardial infarction from stent thrombosis

Enrollment: 142 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-70 year-old
2. Had cardiovascular disease which needed clopidogrel and aspirin
3. Stable enough for gastroscopy

Exclusion criteria

1. Gastroscopy revealed peptic ulcer
2. Had contraindication for gastroscopy
3. Not allowed for gastroscopy by cardiologist

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 2 patient groups, including a placebo group

Repamipide

Active Comparator group

Description:

Rebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred

Treatment:

Drug: Repamipide

placebo

Placebo Comparator group

Description:

A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. It will be prescribed as the same regimen of Rabamipide.

Treatment:

Drug: Placebo