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Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

NCT02166008 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2019-02-27

No results posted yet for this study

Summary

* 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

Conditions

  • Gastric Ulcer Induced by Anti-platelet Agent
  • Duodenal Ulcer Induced by Anti-platelet Agent

Interventions

DRUG

Repamipide

DRUG

Placebo

Sponsors & Collaborators

  • King Chulalongkorn Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-06-30
Completion
2018-06-30

Countries

  • Thailand

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02166008 on ClinicalTrials.gov