Prasugrel Monotherapy versus Combination of Clopidogrel plus Aspirin in Stabilized Patients with Acute Coronary Syndrome after Complex High-risk and Indicated Percutaneous Coronary Intervention (PRADO-CHIP)
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2000
1)Patient must be at least 19 years of age
2)Patients with ACS: unstable angina, non ST-segment elevation MI (NSTEMI), or ST-segment elevation MI (STEMI)
3)Patients undergoing Complex High-risk and Indicated Percutaneous Coronary Intervention(CHIP)
*Definition of CHIP
1.Significant left main (LM) diseases including ostial, body or distal LM bifurcation diseases
2.Ostial stenosis of left anterior descending or left circumflex arteries
3.Bifurcation lesions treated with 2 stents
4.Chronic total occlusion
5.Severe calcified lesion: encircling calcium on coronary angiography
6.Multi-vessel disease involving PCI done in at least two vessels
7.More than 3 stents implanted
8.Diffuse long lesion of more than 38 mm
9.CABG patients: native and/or graft vessels
4) For female patients of childbearing age, those who consent to pregnancy testing and adherence to highly effective birth control methods from enrollment to 5 days after study completion
5) Patients who can verbally confirm understandings of the study objective and clinical follow-up required in this registry, and he/she or his/her legally authorized representative provides written informed consent prior to the study commitment
1) Patients who do not give their consent to join the study or patients who are deemed unsuitable for the study by the investigator
2) Patients with a history of cerebral hemorrhage, transient ischemia attack, or ischemic stroke
3) Patients scheduled for staged PCI
4) Patients with significant active bleeding, bleeding diathesis, and/or coagulopathies (Hb < 10 g/dL before correction, bleeding requiring transfusion in the prior 30 days, abdominal/thoracic/neural surgery in the prior 90 days, patients at high risk for injuries)
5) Patients who are hypersensitive to contrast mediums or antiplatelet drugs (aspirin, clopidogrel, prasugrel)
6) Patients with moderate to severe liver dysfunction (Child Pugh class C)
7) Patients with a life expectancy < 1 year due to non-cardiac disease
8) Patients needing anticoagulation (warfarin, DOAC; direct oral anticoagulant)
9) Pregnant and/or breast feeding patients
10) Patients with galactose intolerance, lactase deficiency, and/or glucose-galactose malabsorption)
11) Patients with major ischemic and/or bleeding events within 1 months after index PCI will be excluded
12) Patents aged 75 years or above
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite endpoint of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and ischemia-driven revascularization ;Composite endpoint of BARC bleeding (type 2, 3, or 5);MACCE (Major Adverse Cardiac and Cerebrovascular Events);Composite endpoint of MACCE (CV death, nonfatal MI, or stroke) plus BARC bleeding (type 2, 3, 5)
- Secondary Outcome Measures
Name Time Method All-cause death ;CV death;nonfatal myocardial infarction;nonfatal stroke;Ischemia driven revascularization;Stent thrombosis (definite or probable) ;BARC bleeding type 3 or 5 ;The safety assessment includes major cardiovascular events, bleeding events and adverse events associated with the study medications. Numbers will be presented as results. ;Vital signs, physical examination