Assessment of Coronary Flow Reserve by Doppler Flow WIre in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Differences Between the Loading Dose of Prasugrel and Ticagrelor .
试验速览
- 阶段
- 4 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- assessment of coronary flow reserve
研究概览
简要总结
Study design Investigators aim to perform a prospective, single-center, investigator-initiated, randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous Coronary Intervention. Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio, to receive a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with non-ST elevation myocardial infarction these drugs will be administered only when the coronary anatomy will be known, to avoid bleeding due to prasugrel, in patients suitable for coronary artery bypass grafting as recommended by European Society of Cardiology guidelines (Class IB) (10). In patients with ST elevation myocardial infarction, instead, prasugrel and ticagrelor will be administrated before the procedure, according to the European Society of Cardiology guidelines (Class IB) (11). Coronary Flow Reserve will be recorded by intracoronary Doppler Flow Wire before the stent implantation and after the procedure at baseline and 2-minute later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions.
Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in patients with acute coronary syndrome, without an increased risk of adverse events for patients neither adjunctive costs for the National Health System.
Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will be measured in venous blood collected at the end of the procedure. . In patients requiring a second Percutaneous Coronary Intervention, for example for multivessel disease, all these measures will be repeated in the same manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention with stent implantation;
- •Patients ≥ 18 and ≤ 75 years old.
- •Signed informed consent;
排除标准
- •• Patients with stable angina;
- •prior myocardial infarction;
- •prior revascularization (Percutaneous Coronary Intervention or coronary artery bypass grafting);
- •Ticagrelor contraindications (history of intracranial hemorrhage, active pathological bleeding, severe hepatic impairment);
- •Prasugrel contraindications (patients weighing less than 60 kg, patients who had previous stroke or transient ischemic attack, patients aged more than 75 years old);
- •major periprocedural complications;
- •suboptimal Percutaneous Coronary Intervention result (residual stenosis > 20%);
- •glomerular filtration rate < 30 ml/min or requiring haemodialysis;
- •Non-sinus rhythm;
- •severe chronic obstructive pulmonary disease;
- •requirement for oral anticoagulant;
- •risk of bleeding or bradycardic events;
- •ejection fraction < 45%;
- •Cardiogenic shock;
- •Severe left ventricular hypertrophy;
- •severe valvular disease;
- •diffuse coronary atherosclerosis;
研究组 & 干预措施
Ticagrelor
Patient randomized to Ticagrelor
干预措施: Assessment of coronary flow reserve (Procedure)
Ticagrelor
Patient randomized to Ticagrelor
干预措施: Percutaneous Coronary Intervention (Procedure)
Ticagrelor
Patient randomized to Ticagrelor
干预措施: Ticagrelor loading (Drug)
Prasugrel
Patient randomized to Prasugrel
干预措施: Assessment of coronary flow reserve (Procedure)
Prasugrel
Patient randomized to Prasugrel
干预措施: Percutaneous Coronary Intervention (Procedure)
Prasugrel
Patient randomized to Prasugrel
干预措施: Prasugrel loading (Drug)
结局指标
主要结局
assessment of coronary flow reserve
时间窗: 2 hours after the loading dose
次要结局
未报告次要终点
研究者
Massimo Mancone
PhD
Azienda Policlinico Umberto I
