Investigator initiated Clinical Trial to Assess the Efficacy and Safety of proton pump inhibitor(Lansoprazole) in coronary artery disease undergoing percutaneous coronary intervention as compared with control.
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008107
- Lead Sponsor
- The Catholic University of Korea, Daejeon St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 300
1.19 years of age or older
2. patients diagnosed
- stable angina
- unstable angina
- NSTEMI
- STEMI
3. Those who are scheduled to receive or are taking double antiplatelet therapy including Aspirin after PCI
4.patients with low to moderate bleeding risk
1. age < 19 years (vulnerable subjects)
2. known allergy to aspirin and clopidogrel
3. A person who is classified as a high-risk group according to the gastrointestinal risk assessment index
4. liver cirrhosis
5. known iron deficiency anemia
6. recent fibrinolytic therapy
7. active cancer
8. end-stage renal failure
9. life expectancy < 1 year
10. co-prescription of NSAIDs, corticosteroid and anticoagulant such as NOAC or warfarin
11. pregnancy or lactation
12. mentally or cognitively disabled people
13. not agree to participate in the study
14. mechanical ventilation with endotracheal intubation
15. persons related unequally to investigators (students and employees)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Combined variables of cardiovascular death, unnamed myocardial infarction, coronary artery revascularization, or ischemic stroke
- Secondary Outcome Measures
Name Time Method ; time from randomization to the first occurrence of gastroesophageal reflux disease, as evidenced by symptomatic, endoscopically confirmed erosive esophagitis