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OpenTrials
Completed

NCT Number: NCT02166008

Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

* 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

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Key information

Conditions

Gastric Ulcer Induced by Anti-platelet Agent Digestive System Diseases Duodenal Diseases Duodenal Ulcer Induced by Anti-platelet Agent Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-70 year-old
  • Had cardiovascular disease which needed clopidogrel and aspirin
  • Stable enough for gastroscopy

Exclusion criteria

  • Gastroscopy revealed peptic ulcer
  • Had contraindication for gastroscopy
  • Not allowed for gastroscopy by cardiologist

Treatment and study plan

Repamipide

Drug

Placebo

Drug

Other names: Placebo will be made in the same configuration of rabamipide

Primary outcomes

  1. number of peptic ulcer by end0scopy

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

King Chulalongkorn Memorial Hospital

Other

Registry information

Official study title

Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jun 18, 2014
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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