EASTYLE (DE-escAlation Strategy for Optimal Ticagrelor Therapy in Acute MYocardiaL Infarction PatiEnts, Prospective, Multicenter, Randomized) Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,312
- 试验地点
- 1
- 主要终点
- Primary endpoint (NACE)
研究概览
简要总结
DAPT de-escalation strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. The EASTYLE trial will evaluate a hybrid DAPT de-escalation strategy (reduced-dose ticagrelor, followed by aspirin early discontinuation) in AMI patients, compared with a conventional DAPT strategy.
详细描述
In ACS patients undergoing percutaneous coronary intervention, conventional dual antiplatelet therapy (DAPT) for patients with acute coronary syndromes undergoing percutaneous coronary intervention comprises aspirin with a potent P2Y12 inhibitor (prasugrel or ticagrelor) for 12 months. Although this approach reduces ischaemic risk, patients are exposed to a substantial risk of bleeding during the stabilized period. Strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. Abbreviation of DAPT duration after 1-6 months, followed by monotherapy with aspirin or a P2Y12 inhibitor, reduces bleeding without an increase in ischaemic events in patients at high bleeding risk, particularly those without high ischaemic risk. Either strategy requires assessment of the ischaemic and bleeding risks of each individual. Previous clinical and laboratory evidence demonstrates that a conventional-dose of ticagrelor has a potent antiplatelet effect, which appears to have a potential to increase the risk of bleeding during the stabilized period. Adjunctive use of aspirin to P2Y12 inhibitor would be important to protect the risk of thrombotic events in AMI patients, which use has a limited benefit with increased bleeding rate during the the stabilized period.
The EASTYLE trial will evaluate clinical benefit of step-down de-escalation DAPT strategy including downgrading of P2Y12 inhibition (from 90 mg to 60 mg ticagrelor at 1 month post-PCI) and abbreviation of DAPT duration (aspirin discontinuation at 3 months post-PCI), compared with a conventional DAPT strategy in AMI patients. This trial will support that the optimal platelet inhibition would be attenuated over time even in AMI patients. The result will make a big step toward precision medicine in the field of antiplatelet treatment in AMI patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with acute myocardial infarction.
- •Age ≥19 year-old
- •Successful PCI with ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; Biotronik AG).
- •Provision of informed consent.
排除标准
- •Any prior event of hemorrhagic stroke or ICH.
- •Active bleeding (e.g., GI bleeding, ICH) or high-risk of serious bleeding.
- •Bleeding diathesis or coagulopathy (e.g., hemoglobin ≤ 10 g/dL or platelet count < 100,000/μL, bleeding needing transfusion within 30 days, and so on).
- •Allergy to stent metal, contrat media, and antiplatelet regimens.
- •Moderate to severe hepatic dysfunction (Child-Pugh class B or C).
- •Need for oral anticoagulation therapy.
- •Current or potential pregnancy.
- •Currently treated with strong CYP3A4 inhibitors.
- •Life expectancy <1 year.
研究组 & 干预措施
Conventional strategy
PCI ~ 12 months: ticagrelor 90 mg twice daily + aspirin 100 mg once daily
干预措施: Conventional strategy (Drug)
De-escalation strategy
PCI ~ 1 month: ticagrelor 90 mg twice daily + aspirin 100 mg once daily
1 ~ 3 months: ticagrelor 60 mg twice daily + aspirin 100 mg once daily
3 ~ 12 months: ticagrelor 60 mg twice daily
干预措施: De-escalation strategy (Drug)
结局指标
主要结局
Primary endpoint (NACE)
时间窗: 12 months
MACCE (all-cause death, non-fatal myocardial infarction, stent thrombosis or non-fatal stroke) + major bleeding (BARC type 2, 3, or 5 bleeding)
次要结局
- Major adverse cardiac and cerebrovascular events (MACCE)(12 months)
- Bleeding events(12 months)
- CV death(12 months)
- MI(12 months)
- All-cause death(12 months)
- Stent thrombosis(12 months)
- Ischemic stroke(12 months)
- Cardiac death, or MI(12 months)
- Cardiac death, MI or stent thrombosis(12 months)
- Cardiovascular death, MI or stroke(12 months)
- TLR(12 months)
- TVR(12 months)
- Any revascularization(12 months)
研究者
Moo Hyun Kim
Professor, Deptartment of Cardiology, Dong-A University Hospital
Dong-A University