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临床试验/NCT02032303
NCT02032303Unknown4 期

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 .

Azienda Policlinico Umberto I1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Patient randomized to Ticagrelor

干预措施: Assessment of coronary flow reserve (Procedure)

Ticagrelor

Active Comparator

Patient randomized to Ticagrelor

干预措施: Percutaneous Coronary Intervention (Procedure)

Ticagrelor

Active Comparator

Patient randomized to Ticagrelor

干预措施: Ticagrelor loading (Drug)

Prasugrel

Active Comparator

Patient randomized to Prasugrel

干预措施: Assessment of coronary flow reserve (Procedure)

Prasugrel

Active Comparator

Patient randomized to Prasugrel

干预措施: Percutaneous Coronary Intervention (Procedure)

Prasugrel

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimo Mancone

PhD

Azienda Policlinico Umberto I

研究点 (1)

Loading locations...

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