Aspirin and a PoTent P2Y12 Inhibitor versus Aspirin and Clopidogrel Therapy in Patients Undergoing Elective Percutaneous Coronary Intervention for Complex Lesion Treatment
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0003970
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3500
1 a patient over the age of nineteen
2 Those who fully understand the risks and benefits of participating in the study and who have prior consent;
3 Unstable angina patient
4 Patients who are scheduled or have already received percutaneous coronary artery intervention due to coronary complex lesions
? Coronary artery complex lesions are defined as those that are accompanied by one or more of the following nine.
1) Medina branch lesions (1,1/1,1,0,1,1) with lateral branch sizes greater than 2.5 mm
2) Target vessels are chronic complete pulmonary lesions (=3 months)
3) If it is an unprotected left-wedge lesion (the left-wedge basin lesion also includes a non-vigilant basin lesion).)
4) The inserted stent is a long lesion with a length of 38mm or more.
5) If a coronary artery intervention is performed in two or more major coronary arteries at a time due to a multivascular disease.
6) If multiple stents are required (£3 more stent per patient)
7) In case of coronary stent re-stenosis lesion
8) Serious coronary calcification lesions (encircling calcium in angiography)
9) In case of left - hand, left - hand, and right - hand coronary artery entrance lesions
1 In case of hemodynamically unstable or psychotropic shock.
2 Serious bleeding (brain bleeding, gastrointestinal bleeding, hematuria, haemostasis, etc.)
3 In the past, there has been a cerebral hemorrhage, a routine ischemia, or a stroke.
4 Sensitive to contrast agents or research drugs (aspirin, prasugrel, clopidogrel)
5 Pregnant or pregnant woman with pregnancy plans during the research period
6 Expected life is less than a year or research protocol cannot be followed due to a shared disease other than the heart;
7 Biomarker positive ACS
8 Patients taking prasugrel or ticagrel with ACS within 1 year
9 If you are older than 75 or weigh less than 60kg
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method at 1 year Major heart events (death, myocardial infarction, or stent thrombosis)
- Secondary Outcome Measures
Name Time Method (Any revascularization);All deaths, myocardial infarction, stent thrombosis, sum of all vascular procedures.;bleeding (BARC type 3 or 5);(All-cause death);(Cardiac death);(Myocardial infarction);(Stent thrombosis) (definite or probable);(TLR, target-lesion revascularization);(TVR, target-vessel revascularization);bleeding (BARC type 2, 3 or 5);?NACE (Net adverse clinical events, MACE + BARC type 3 or 5 bleeding)