IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)
研究概览
简要总结
The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. However, eptifibatide can also be injected directly into the heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in the heart. This new way of giving the drug is being studying.
详细描述
The primary objective of the IC-TITAN study is to demonstrate that an IC bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the ER will result in significant additional clot resolution in vivo when compared with an IC injection of placebo (saline). The primary endpoint chosen to evaluate this hypothesis is the improvement in percent diameter stenosis of the culprit artery following the IC bolus administration of eptifibatide vs. IC placebo (saline) as assessed with quantitative coronary angiography (QCA).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (men or women) at least 18 years of age and
- •Presenting with ischemic chest discomfort >20 minutes and <6 hours of duration suggestive of acute myocardial infarction
- •ST elevation >1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) in two contiguous precordial leads
排除标准
- •Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation
- •Uncontrolled hypertension (SBP>180 OR DBP >110) at time of enrollment
- •Ventricular fibrillation or ventricular tachycardia requiring DC cardioversion
- •Sinus bradycardia (HR <50/min), third degree or advanced second degree heart block.
- •Known pregnancy
- •New or suspected new left bundle branch block
- •BIOCHEMICAL
- •Known thrombocytopenia (platelet count <100,000)
- •Known severe renal insufficiency (creatinine >4.0 mg/dL)
- •INCREASED BLEEDING RISK
- •Active or recent (<1 year) bleeding or gastrointestinal hemorrhage
- •Major surgery <1 month
- •Known coagulopathy, platelet disorder or history of thrombocytopenia: If a patient is known to be on chronic warfarin therapy, the International Normalized Ratio (INR) must be known to be <1.6 in order for the patient to be included
- •Known neoplasm
- •Any history of hemorrhagic cerebrovascular disorder or active intracranial pathology
- •MEDICATIONS
- •Administration of a fibrinolytic agent within 7 days
- •Known allergy or contraindication to eptifibatide OR aspirin OR heparin
- •Treatment with another GP IIb/IIIa inhibitor within 7 days
研究组 & 干预措施
1
Intracoronary injection of eptifibatide
干预措施: eptifibatide (Drug)
2
Intra-coronary injection of normal saline.
干预措施: normal saline (Drug)
结局指标
主要结局
Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)
时间窗: 30 days
次要结局
未报告次要终点
研究者
C. Michael Gibson, MS, MD
Principal Investigator
Brigham and Women's Hospital