跳至主要内容
临床试验/NCT02792712
NCT02792712Unknown4 期

Ticagrelor Versus Clopidogrel in Myocardial Salvage in Patients With ST-elevation Myocardial Infarction (STEMI) Undergoing Primary Percutaneous Coronary Intervention: A Magnetic Resonance Imaging Study (TIGER Study)

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1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
200
试验地点
1
主要终点
Compare myocardial infarct size (myocardial salvage index %) as assessed by CE-MRI between 300-mg clopidogrel group and 180-mg ticargrelor group

研究概览

简要总结

Therefore, in this study, we try to evaluate the impact of clopidogrel loading dose 300mg vs. ticagrelor 180 mg on myocardial injury as measured by contrast-enhanced magnetic resonance imaging (CE-MRI) in STEMI patients undergoing primary PCI.

详细描述

All STEMI patients will be loaded with dual oral antiplatelet therapy of 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before PCI, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel QD or 90 mg ticagrelor BID. The duty interventional cardiologists will be responsible for patient randomization based on a pre-defined randomization chart. As it is a usual practice in Taiwan for door-to-balloon time to be within 90 minutes, we hence do not expect any impact on study results due to D2B time variation.

All STEMI patients will receive loading dose of dual oral antiplatelet therapy with 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before PCI, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel QD or 90 mg ticagrelor BID.

The primary variable is to compare myocardial salvage index (in %) as assessed by CE-MRI between 300-mg clopidogrel group and ticargrelor group. Enzymatic infarct size will also be assessed, and two methods will be used to decide that. The first is cardiac troponinI 72 hours after pain onset , while the other is peak CK level after pain onset. Sampling timing of CK will be judged by the caring physicians.

The secondary objectives include: myocardial infarct size (% of LV mass), the extent of MVO, the number of segments with >75% of infarct transmurality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of informed consent prior to any study specific procedures
  • Adult patients aged 20 years or older
  • STEMI within 12 hours of onset, defined as:presence of chest pain for >30 minutes and <12 hours after symptom onset; ST-segment elevation >1 mm in ≥2 contiguous leads or presumably a new-onset left bundle-branch block on electrocardiogram.
  • STEMI patients planned for PPCI

排除标准

  • STEMI > 12 h of onset
  • History of renal dysfunction requiring dialysis
  • Evidence of malignant diseases
  • Unwillingness to give out consent
  • Contraindicated for ticagrelor or clopidogrel

研究组 & 干预措施

STEMI_MRI_Ticagrelor

Experimental

A Magnetic Resonance Imaging Study in myocardial salvage in patients with ST-Elevation myocardial infarction (STEMI) undergoing pRimary percutaneous coronary intervention - Ticagrelor Arm

干预措施: Ticagrelor (Drug)

STEMI_MRI_Clopidogrel

Active Comparator

A Magnetic Resonance Imaging Study in myocardial salvage in patients with ST-Elevation myocardial infarction (STEMI) undergoing pRimary percutaneous coronary intervention - Clopidogrel Arm

干预措施: Clopidogrel (Drug)

结局指标

主要结局

Compare myocardial infarct size (myocardial salvage index %) as assessed by CE-MRI between 300-mg clopidogrel group and 180-mg ticargrelor group

时间窗: 4-10 days after the index event

次要结局

未报告次要终点

研究者

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

vghtpe user

Tao-Cheng Wu, MD, PhD, Division of Cardiology, Department of Medicine

Taipei Veterans General Hospital, Taiwan

研究点 (1)

Loading locations...

相似试验