OPTIMIZE-APT: Tailored Versus Conventional Antiplatelet Therapy After Intravascular Imaging-guided Drug-eluting Stent Implantation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3,944
- 试验地点
- 42
- 主要终点
- 3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)
研究概览
简要总结
Objectives: To assess the safety of tailored antiplatelet therapy (short DAPT followed by P2Y12 inhibitor alone strategy) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT)
Hypothesis: Tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) is superior to conventional antiplatelet strategy in terms of clinically relevant bleeding and noninferior for ischemic composite adverse events in patients who received intravascular imaging-guided optimized DES implantation. (Optimized stent evaluated by on-site IVUS/OCT could act as an essential criterion for decision making for tailored antithrombotic strategy)
详细描述
Objective: To assess the safety of tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT)
Design: Prospective, open label, multi-center, dual arm, randomized trial Number of Subjects 3,944 subjects (1972:1972) Study Population: Patients with coronary artery disease undergoing imaging-guided PCI
Study Design:
- Eligible subjects will be randomized 1:1 to a) conventional DAPT strategy or b) tailored anti-platelet strategy (short DAPT followed by P2Y12 inhibitor alone) after optimized DES implantation guided by intravascular imaging.
- All subjects will be clinically followed at 1(or 3), 6, and 12, 18, 24, 36, 48, 50 months
Co-primary Endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥19 years
- •Typical chest pain or objective evidence of myocardial ischemia suitable for PCI
- •Significant de novo coronary artery lesions suitable for DES implantation
- •Patients who underwent optimized stent implantation either by IVUS or OCT
- •Using IVUS
- •MSA >5.5 mm2, or MSA >90% of the MLA at the distal reference segment
- •Plaque burden <50% with 5 mm of both stent edge
- •No edge dissection; thrombus or plaque protrusion occupying < 10% of the stent area
- •Using OCT
- •MSA >4.5 mm2, or MSA >90% of the MLA at the distal reference segment
- •No significant malapposition
- •No significant edge dissection†; thrombus or plaque protrusion occupying < 10% of the stent area
- •(*Significant malapposition is defined as strut separation ≥ 0.3 mm from the vessel wall extending over a length > 3 mm.
- •†Significant dissection is defined as a dissection penetrating the medial layer and extending over more than one quadrant.)
- •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
排除标准
- •Angiographic exclusion criteria: any of the followings
- •Bypass graft lesions
- •Lesions in which impaired delivery of imaging catheters is expected:
- •Extreme angulation (≥90°) proximal to or within the target lesion.
- •Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
- •Heavy calcification proximal to or within the target lesion.
- •In-stent restenosis
- •Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
- •Persistent thrombocytopenia (platelet count <80,000/μl)
- •Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months
- •A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin
- •Patients requiring long-term oral anticoagulants or cilostazol
- •Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
- •A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
- •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- •History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction
- •Life expectancy < 1 years for any non-cardiac or cardiac causes
- •Cardiogenic shock at the index admission
- •Patient's pregnant or breast-feeding
- •Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)
- •Unwillingness or inability to comply with the procedures described in this protocol.
研究组 & 干预措施
Tailored Arm
Patients with CCS receive 1 month of DAPT with aspirin plus clopidogrel, followed by 11 months of clopidogrel monotherapy. Patients with ACS receive 3 months of DAPT with aspirin plus a potent P2Y12 inhibitor (ticagrelor or prasugrel), followed by 9 months of potent P2Y12 inhibitor monotherapy.
干预措施: aspirin (Drug)
Conventional Arm
The intended regimen is 12 months of DAPT with aspirin plus clopidogrel for CCS or aspirin plus a potent P2Y12 inhibitor (ticagrelor or prasugrel) for ACS. For patients with CCS, a minimum DAPT duration of 6 months is permitted at the treating physician's discretion.
干预措施: aspirin (Drug)
结局指标
主要结局
3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)
时间窗: 12 month
3\) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)
1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]
时间窗: 12 month
1\) clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\]
2) net clinical outcome defined as a composite of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding [BARC 2, 3, or 5]
时间窗: 12 month
2\) net clinical outcome defined as a composite of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding \[BARC 2, 3, or 5\]
Composite ischemic endpoint
时间窗: 12 month
Ischemic composite adverse event of all-cause death, myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)
Net adverse clinical events (NACE)
时间窗: 12 month
Net clinical outcome defined as a composite of all-cause death, myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding \[BARC 2, 3, or 5\]
Clinically relevant bleeding
时间窗: 12 month
Clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\]
次要结局
- 1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)(12 month)
- 2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group(1 or 3 month)
- Individual components of the co-primary endpoints(12 month)
- Cardiovascular death(12 month)
- Stroke(12 month)
- Individual BARC bleeding categories(12 month)
- Stent strut coverage in the OCT substudy(1 or 3 month)
- Individual components of the composite ischemic endpoint(12 month)
研究者
Seung-Whan Lee, M.D., Ph.D.
Part of Cardiology, Principal Investigator, associate professor
Asan Medical Center