2024-514224-17-00招募中2 期
Ticagrelor monotherapy after coronary stenting in patients with acute myocardial infarction - A prospective single-centre, single-arm phase II study
Vaestra Goetalandsregionen, Vaestra Goetalandsregionen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.
研究概览
简要总结
A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Men or women at least 18 years old.
- •Pre- or intra-procedure treatment with ticagrelor.
- •Coronary stenting with an everolimus-eluting stent (EES) due to NSTEMI or STEMI, with post-procedure diameter stenosis <50% and post-procedure Thrombolysis In Myocardial Infarcton (TIMI) flow grade
- •Subject has not yet received any post-procedure dose of aspirin or any post-procedure dose of a different P2Y12 inhibitor than ticagrelor (loading dose or pre-PCI maintenance dose of aspirin and/or a different P2Y12 inhibitor is allowed).
- •Subject has signed and dated the informed consent form.
排除标准
- •Planned PCI or any planned surgical intervention within the next 6 months.
- •Any treated lesion within an arterial or venous graft.
- •Any additional lesion(s) that need(s) a staged revascularization.
- •Known ejection fraction <30%.
- •Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
- •Any life-threatening conditions or medical comorbidity resulting in life expectancy < 12 months.
- •Participation in any investigational study that has not yet reached its primary endpoint, and for which monotherapy with ticagrelor may affect the primary outcome (as per the judgement of the investigator).
- •Patients who medicate with a potent CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
- •Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception.
- •Expected inability (by the investigator) to comply with the protocol
- •Subjects incapable to giving consent personally
- •Any indication for chronic anticoagulant therapy.
- •Positive COVID-19 antigen or PCR test regardless of symptoms.
- •History of definite stent thrombosis.
- •Left main coronary artery stenting.
- •Stent thrombosis/restenosis as a culprit lesion.
- •Visible thrombus on angiography after PCI.
- •Usage of glycoprotein IIb/IIIa inhibitors.
- •Any bifurcation lesion with stenting of both branches.
结局指标
主要结局
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.
次要结局
- Any spontaneous myocardial infarction (time-to-event)
- All-cause mortality (time-to-event)
- The composite of cardiac death, spontaneous target vessel myocardial infarction or definite or probable stent thrombosis within 12 months.
- Time to the following outcomes at 3- and 12 months (unless specified): Bleeding Academic Research Consortium (BARC) types 3 or 5 bleeding (time-to-event)
- Definite or probable stent thrombosis or spontaneous target vessel myocardial infarction (time-to-event)
- Platelet reactivity as assessed by the ADP-test (multiplate), at 24 hours and 3 months.
研究者
Oskar Angerås
Scientific
Vaestra Goetalandsregionen
研究点 (1)
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