Prospective, Randomized, Open Label Trial of 6 Months vs. 12 Months Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,100
- 试验地点
- 24
- 主要终点
- Net MACCE
研究概览
简要总结
OBJECTIVE OF THE STUDY: To test the hypothesis that 6 months DAPT (Dual anti-platelet therapy) after second generation DES (Drug Eluting Stent) implantation in STEMI (ST elevation Myocardial Infarction) is not inferior to 12 months DAPT in terms of clinical outcomes (composite endpoint of all-cause mortality, any MI, any revascularization, stroke and major bleeding at 18 months after randomization).
The trial will incorporate two registers studying respectively the safety outcomes of Bivalirudin and Prasugrel combination and Bivalirudin and Ticagrelor combination at 2 and 30 days. Finally the trial design permits assessment of the clinical outcomes after primary PCI for treatment of STEMI with the new Resolute Integrity (Medtronic Santa Rosa Ca, USA) stent at 30 days and 6 months.
详细描述
BACKGROUND OF THE STUDY: First generation DES (Drug Eluting Stents) have significantly reduced the restenosis rates compared to the BMS (Bare Metal Stents) but have raised concerns regarding higher rates and ongoing propensity for stent thrombosis. Based on these concerns current guidelines advocate dual antiplatelet therapy (DAPT, aspirin plus P2Y12 inhibitor) to be continued for up to 1 year after DES implantation. Large registries analyzing recent data now challenge these recommendations and suggest no increase in mortality or (late) stent thrombosis when DAPT is discontinued after 6 months.
STUDY DESIGN: This is a prospective, randomized, open-label trial testing the hypothesis that 6 months DAPT after second generation drug eluting stent (DES) implantation in STEMI is not inferior to 12 months DAPT in terms of clinical outcomes. Patients with STEMI undergoing primary PCI will be enrolled at presentation. Only those patients who are event-free (death, MI, ST, TVR/TLR or unscheduled revascularization with DES in the first 6 months and stroke or bleeding requiring discontinuation of DAPT) and on DAPT at 6 months after primary PCI will be randomized (1:1 fashion) between single (aspirin) versus dual antiplatelet therapy (aspirin plus P2Y12) for an additional 6 months (up to 12 months after primary PCI) and assessed at 18 months post randomization.
STUDY POPULATION: Patients between 18 and 85 years, presenting with STEMI undergoing PCI with DES implantation.
INTERVENTION: Patients, who are event-free and stil on DAPT at 6 months after primary PCI will be randomized (1:1 fashion) between single (aspirin) versus dual antiplatelet therapy (aspirin plus P2Y12) for an additional 6 months (up to 12 months after primary PCI).
PRIMARY STUDY PARAMETERS/OUTCOME OF THE STUDY:
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI patients between 18-85 years who underwent primary PCI with DES implantation.
排除标准
- •Intolerance to Aspirin, Prasugrel, Ticagrelor, Heparin, Bivalirudin, Zotarolimus or Everolimus.
- •Known bleeding diathesis or known coagulopathy.
- •Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.
- •History of stent thrombosis
- •DES in main left coronary artery
- •Active bleeding, known bleeding diathesis or known coagulopathy.
- •Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.
- •Oral anticoagulant therapy with Coumadin derivates
- •Malignancies or other comorbidity with a life expectancy of less than one year or that may result in protocol noncompliance
- •Pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)
- •Exclusion criteria randomization:
- •Occurrence of death, myocardial infarction, stent thrombosis and target vessel or lesion revascularization during the first 6 months after inclusion.
- •Stroke or bleeding requiring discontinuation of DAPT during the first 6 months after inclusion.
- •Oral anticoagulant therapy
- •Exclusion criteria
- •Intolerance to Prasugrel, Ticagrelor, Bivalirudin.
- •Known bleeding diathesis or known coagulopathy
- •Report Resolute Integrity Exclusion criteria
- •See exclusion criteria enrollment DAPT-STEMI protocol
研究组 & 干预措施
6 months DAPT
Dual antiplatelet therapy consisting of aspirin (ASA) and prasugrel or ticagrelor will be discontinued after randomisation.
干预措施: 6 months DAPT (Other)
12 months DAPT
Dual antiplatelet therapy consisting of aspirin (ASA) and prasugrel or ticagrelor will be continued till 12 months after enrollment in the study
干预措施: 12 months DAPT (Other)
结局指标
主要结局
Net MACCE
时间窗: 18 months
DAPT-STEMI trial: Composite endpoint of all cause mortality, any myocardial infarction (MI) , any revascularization, stroke and major bleeding (TIMI) (net MACCE) at 18 months after randomization
次要结局
- All cause mortality, MI, Stroke, ST and bleeding(30 days)
- All cause mortality, MACCE, TIMI(18 months)
- Cardiac Mortality(30 days)
- all cause mortality(9 months)
- Target vessel MI(30 days)
- Bleeding(18 months)
- Target vessel failure(18 months)
- Bleeding (BARC)(30 days)
- ST definite/probable(18 months)
- MI(18 months)
- Target lesion failure(18 months)
- Stroke(2 days)
- Bleeding BARC(2 days)
- Cardiac mortality(2 days)
- Target vessel revascularization(18 months)
- Target lesion revascularization(18 months)
- All cause mortality(30 days)
- ST following ARC(30 days)
- stroke(9 months)
- net MACCE(6 months)
- All MI(30 days)