Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

Duodenal Ulcer Induced by Anti-platelet Agent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166008
• Other study ID #: RP006
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2014
• Est. completion date: June 2018

Study information

• Verified date: February 2019
• Source: King Chulalongkorn Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Repamipide

• Placebo

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Patumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of peptic ulcer by end0scopy		1 year

External Links

•   Institutional review board, Faculty of medicine, Chulalongkorn University