Aspirin Plus Ticagrelor for 1 Month Followed by 5 Months Ticagrelor Monotherapy Versus Aspirin Plus Ticagrelor for 12 Months in Acute Coronary Syndrome Patients With Drug-coated Balloon: a Multicentre, Randomized, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,948
- 试验地点
- 1
- 主要终点
- Net adverse clinical events (NACE)
研究概览
简要总结
Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated to the balloon. Treating ISR lesions with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.
Bleeding after PCI remains a substantial clinical problem. Bleeding post-PCI increases the risk of adverse outcomes such as death, non-fatal myocardial infarction, and prolongs hospital stay. Clinical data has suggested that major bleeding post-PCI would increase the risk of mortality 5.7-fold. The antiplatelet medications are the major cause of bleeding events post-PCI.
Current guidelines for stents recommended DAPT of aspirin plus a P2Y12 inhibitor for at least 12 months after stent implantation in patients with the acute coronary syndrome. Compared with the DES, because of the absence of metal inside the coronary artery, the use of DCB might theoretically allow shorter duration antiplatelet therapy. However, the optimal course of DAPT for the DCB treated patients remains controversial.
In 2013, the consensus from the German group suggested that for the acute coronary syndrome, DAPT should be used for 12 months. The consensus of DAPT developed by the European Society of Cardiology (ESC) in 2017 stated that "in patients treated with DCB, dedicated clinical trials investigating the optimal duration of DAPT are lacking." So far, there are no randomized data showing the optimal DAPT duration for the DCB treated patients.
In the current study, we use Aspirin + Ticagrelor for 1-month followed by Ticagrelor monotherapy for 5-month, afterward, Aspirin monotherapy for 6 months to be the antiplatelet regimen in the experimental arm, to compare with the Reference arm, which is Aspirin + Ticagrelor for 12-month in a non-inferiority statistical assumption, aiming to investigate the optimal duration of the DAPT in ACS patients after DCB treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an indication for PCI due to acute coronary syndrome
- •All target lesions can be successful treatment of PCI with drug-coated balloon (DCB)
- •Patients who are able to complete the follow-up and compliant to the prescribed medication
排除标准
- •Under the age of 18 or Older than 80 years old
- •Unable to give informed consent
- •Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
- •Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.
- •Currently participating in another trial and not yet at its primary endpoint
- •Planned elective surgery
- •Concurrent medical condition with a life expectancy of less than 1 years
- •Previous intracranial haemorrhage
- •Need long-term oral anticoagulant therapy
- •Cardiogenic shock
- •Previous stent implantation 6 month
- •In-stent thrombosis
- •Target lesion located in surgical conduit
研究组 & 干预措施
Experimental arm
1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months
干预措施: Aspirin 100mg for 1-month (immediately after PCI) (Drug)
Experimental arm
1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months
干预措施: Ticagrelor 90mg for 6-month (immediately after PCI) (Drug)
Experimental arm
1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months
干预措施: Aspirin 100mg for 6-month (6-month post PCI) (Drug)
Reference arm
12-month Aspirin plus Ticagrelor
干预措施: Aspirin 100mg for 12-month (immediately after PCI) (Drug)
Reference arm
12-month Aspirin plus Ticagrelor
干预措施: Ticagrelor 90mg for 12-month (immediately after PCI) (Drug)
结局指标
主要结局
Net adverse clinical events (NACE)
时间窗: 12 months
NACE is a composite clinical endpoint of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events
次要结局
- All-cause death(1, 6 and 12 months)
- Definite/Probable stent thrombosis rates(1, 6 and 12 months)
- Target vessel myocardial infraction (TV-MI)(1, 6 and 12 months)
- Any MI(1, 6 and 12 months)
- Clinically-indicated target vessel revascularization(1, 6 and 12 months)
- Rate of NACE(1 and 6 months)
- Patient-oriented Composite Endpoint (PoCE)(1, 6 and 12 months)
- Any ischemic or bleeding event(1, 6 and 12 months)
- BARC type 3 or 5 bleeding events(1, 6 and 12 months)
- BARC type 2 ,3 or 5 bleeding events(1, 6 and 12 months)
- Device-oriented Composite Endpoint (DoCE)(1, 6 and 12 months)
- Target vessel failure (TVF)(1, 6 and 12 months)
- BARC defined type 2 bleeding events(1, 6 and 12 months)
- Cardiac death(1, 6 and 12 months)
- Clinically individual target lesion revascularization (CI-TLR)(1, 6 and 12 months)
- Any stroke(1, 6 and 12 months)
- Any revascularization(1, 6 and 12 months)
研究者
LingTao
Professor in cardiology, Director of the department of Cardiology
Xijing Hospital