Perioperative Antiplatelet therapy in patients with drug-eluting Stent undergoing noncardiac SURgEry
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0002907
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
1.Subject was ? 19 years of age.
2Patients who successfully implanted at least one or more coronary drug-eluting stents
3.Patients scheduled for surgery at 12 months after stenting.
4.Patients scheduled for elective non-cardiac surgery
5.The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
1.Patient who currently have a symptom of acute coronary syndrome or myocardial infarction within 1 month
2.Patient who have dyspnea on exertion(NYHA Fc III~IV) due to severe left ventricular dysfunction(EF=30%) or severe valvular heart disease
3.Patient who have Intolerance for aspirin
4.Patient who need for anticoagulation therapy
5.Emergent operation
6Cardiac surgery
7Very high bleeding risk(ex, Intra-cranial surgery, Intra-spinal surgery, Retinal surgery)
8Patient who have significantly abnormal findings which identified violation for safety by investigator on physical examination, blood test and electrocardiogram.
9Concurrent medical condition with a life expectancy of less than 1 years
10Pregnant and/or lactating women
11Patient was unable to provide written informed consent or participate in log-term follow up
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of all-cause death, stent thrombosis, myocardial infarction, and stroke
- Secondary Outcome Measures
Name Time Method All cause death;Cardiac death;Myocardial infarction;Stroke;Stent thrombosis;Life threatening bleeding;Major bleeding;Repeat revascularization