Coronary Artery Disease
Conditions
Keywords
Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Complex Coronary Lesion
Brief summary
This study is a prospective, open label, two-arm, randomized multicenter trial to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective percutaneous coronary intervention with drug eluting stents for complex coronary lesions.
Detailed description
Over the past several decades, dual antiplatelet therapy (DAPT) with the combination of aspirin and a P2Y12 inhibitor has become an essential treatment in patients undergoing percutaneous coronary intervention (PCI) to reduce ischemic events. Although the optimal duration of DAPT still remains controversial in patients with coronary artery disease, the recommended duration of maintenance of DAPT for patients undergoing PCI with drug-eluting stent is ≥12 months for those with acute coronary syndrome (ACS), and ≥6 months for those with stable coronary artery disease according to the current guidelines. However, individualized approach based on ischemic versus bleeding risks assessment is needed to determine the optimal duration of DAPT in various population. Several studies reported that patients undergoing PCI for complex lesions had significantly higher rates of ischemic events than those with non-complex lesions. Moreover, prolonged DAPT of aspirin and clopidogrel more than 1 year significantly reduced the risk of cardiac ischemic events up to 44% in patients undergoing PCI for complex coronary lesions, and the current guideline recommends prolonged DAPT duration may be considered in patients undergoing complex PCI. Apart from prolonged use of DAPT, use of more potent P2Y12 inhibitor than clopidogrel may be another strategy to reduce ischemic events in patients undergoing PCI for complex coronary lesions. Prasugrel, a new thienopyridine, inhibits platelet aggregation more rapidly and potently than clopidogrel. In the TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel) study, prasugrel reduced ischemic events compared with clopidogrel in patients with acute coronary syndrome. Moreover, low dose prasugrel also reduced ischemic events without an excessive bleeding risk in Japanese population. Therefore, DAPT of aspirin and prasugrel would reduce recurrent ischemic events than DAPT of aspirin and clopidogrel in patients undergoing PCI for complex lesions, a high risk group of ischemic events, even when they do not present with myocardial infarction. So far, there have been no data on this issue. The aim of the SMART-ATTEMPT (Aspirin and a PoTent P2Y12 inhibitor versus aspirin and clopidogrel Therapy in patients undergoing Elective percutaneous coronary intervention for coMPlex lesion Treatment) trial is to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective PCI for complex lesions.
Interventions
DRUGDual antiplatelet therapy with a P2Y12 inhibitor plus aspirin
Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin will be given according to the allocated arms in patients undergoing elective percutaneous coronary intervention for complex coronary lesion 1. Prasugrel plus Aspirin arm 2. Clopidogrel plus Aspirin arm
Sponsors
Samsung Medical Center
Inje University Ilsan Paik Hospital
Seoul St. Mary's Hospital
Mediplex Sejong Hospital
Chonnam National University Hospital
Sejong General Hospital
Wonkwang University Hospital
Gachon University Gil Medical Center
Keimyung University Dongsan Medical Center
Chungbuk National University Hospital
Yeungnam University Hospital
Chungnam National University Hospital
Wonju Severance Christian Hospital
Konkuk University Chungju Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Dankook University
Incheon St.Mary's Hospital
Gyeongsang National University Hospital
Soonchunhyang University Hospital
Ewha Womans University Seoul Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ① Subject must be at least 19 years of age * ② Subject who can verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure * ③ Patients undergoing elective PCI as follows: 1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5 mm size 2. Chronic total occlusion (≥3 months) as target lesion 3. PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions) 4. Long coronary lesions (expected stent length ≥38 mm) 5. Multi-vessel PCI (≥2 vessels treated at one PCI session) 6. Multiple stent needed (≥3 stents per patient) 7. In-stent restenosis lesion as target lesion 8. Severely calcified lesion (encircling calcium in angiography) 9. Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery
Exclusion criteria
* ① Hemodynamic instability or cardiogenic shock * ② Subjects with serious bleeding (Intracerebral hemorrhage, gastrointestinal bleeding, hematuria, hemoptysis, and etc.) * ③ Previous history of intracerebral hemorrhage, transient ischemic attack, or stroke * ④ Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel, and prasugrel) * ⑤ Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study * ⑥ Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) * ⑦ Patients presenting with biomarker positive acute coronary syndrome * ⑧ Patients chronically taking prasugrel or ticagrelor (≥1 week) * ⑨ Subjects ≥75 years of age or \<60 kg of body weight * ⑩ Patients taking warfarin or novel oral anticoagulants (dabigatran, rivaroxaban, edoxaban, or apixaban) * Eligible patients will be randomly assigned to treatment arms, stratified by participating centers, presence of diabetes mellitus, and stent types.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events (MACE) | 1-year after randomization | A composite of death, myocardial infarction, or stent thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death | 1-year after randomization | Death by any cause |
| Cardiac death | 1-year after randomization | Death by cardiac cause |
| Myocardial infarction | 1-year after randomization | Myocardial infarction |
| Stent thrombosis | 1-year after randomization | Definite or probable stent thrombosis |
| Target lesion revascularization | 1-year after randomization | Repeat revascularization for target lesion of index PCI |
| Target vessel revascularization | 1-year after randomization | Repeat revascularization for target vessel of index PCI |
| Any revascularization | 1-year after randomization | Any repeat revascularization |
| A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization | 1-year after randomization | A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization |
| A composite of all-cause death/myocardial infarction | 1-year after randomization | A composite of all-cause death/myocardial infarction |
| A composite of cardiac death/myocardial infarction | 1-year after randomization | A composite of cardiac death/myocardial infarction |
| Cerebrovascular accident | 1-year after randomization | Cerebrovascular accident |
| A composite of all-cause death/myocardial infarction/cerebrovascular accident | 1-year after randomization | A composite of all-cause death/myocardial infarction/cerebrovascular accident |
| A composite of cardiac death/myocardial infarction/cerebrovascular accident | 1-year after randomization | A composite of cardiac death/myocardial infarction/cerebrovascular accident |
| A composite of cardiac death/myocardial infarction/stent thrombosis | 1-year after randomization | A composite of cardiac death/myocardial infarction/stent thrombosis |
| Bleeding by BARC types 3 or 5 | 1-year after randomization | Bleeding defined by Bleeding Academic Research Consortium (BARC) types 3 or 5 |
| Bleeding by BARC types 2, 3, or 5 | 1-year after randomization | Bleeding defined by BARC types 2, 3 or 5 |
| Net adverse clinical events | 1-year after randomization | MACE + bleeding by BARC types 3 or 5 |
Countries
South Korea
Contacts
CONTACTJoo-Yong Hahn, MD, PhD
CONTACTKi hong Choi, MD, PhD
STUDY_CHAIRJoo-Yong Hahn, MD, PhD
Samsung Medical Center
Outcome results
None listed