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临床试验/NCT00445263
NCT00445263终止4 期

Treatment by Anti GP IIb/IIIa in the Setting of a Strategy of Early Coronarography to Patients With an Acute Coronary Syndrome Without ST Elevation

Hospital Avicenne1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
170
试验地点
1
主要终点
Mortality, Myocardial Infarction and Revascularization in Emergency

研究概览

简要总结

The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main evolutionary risk of these patients is the coronary thrombosis and its self complications. The platelets aggregation plays a major role in the physiopathology of the ACS. The therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of these products in the ACS with or without ST elevation, associated or not to coronarography, has clearly been demonstrated. This profit is more marked when patients are at high risk of complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at "high risk" for whom a coronarography is planned, in the last international recommendations of the European Cardiology Society (ESC), the American Heart Association and the American College of Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on coronarography with discordant results. The ideal delay of realization of this coronarography is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again, patients at high risk seem to benefit the more of such a strategy if it is set precociously.

Objective To compare an invasive strategy associating an early administration of tirofiban and a coronarography achieved in the 6 hours after the randomization to a conservative strategy in a population of high risk patients with ACS without ST elevation.

Design Multicentric, prospective, randomized study.

详细描述

Patient's selection Patient of more than 18 years with a ACS defined by a thoracic pain of more than 20 minutes that occurred during the last 24 hours, anomalies on EKG and one of the following criteria : diabetes; recurrence of coronary pain; precocious pain post-myocardial infarction; falling of the ST segment of > 1 mm; transient elevation of the ST segment > 1 mm; elevation of the I troponin, T troponin or CPK MB; hemodynamic instability; ventricular arrhythmia; TIMI score > 5

Therapeutic modes All patients receive : aspirin, clopidogrel, enoxaparine. Trinitrin and analgesics are at the clinician's appreciation. Besides, either they receive an anti GP IIb/IIIa: tirofiban (Agrastat®) and are oriented in cardiology to have a coronarography in the six hours or they are oriented in cardiology to receive the classical treatment, guided by the investigations searching for signs of myocardial ischemia.

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

入选标准

  • High risk ACS without ST elevation

排除标准

  • Age <18 years
  • Pregnancy
  • Persistence of the ST elevation
  • Recent left branch block
  • Cardiac failure or cardiogenic shock (Kilip 3 or 4)
  • Treatment by anti-vitamin K
  • Contra-indication to the use of one of the following treatments: aspirin, clopidogrel, enoxaparine, anti GP IIb/IIIa (tirofiban)

研究组 & 干预措施

Early Invasive strategy

Experimental

Tirofiban and coronarography within 6 hours

干预措施: TIROFIBAN (Drug)

Early Invasive strategy

Experimental

Tirofiban and coronarography within 6 hours

干预措施: CORONAROGRAPHY (Procedure)

Delayed invasive strategy

Active Comparator

Coronarography after 6 hours

干预措施: CORONAROGRAPHY (Procedure)

结局指标

主要结局

Mortality, Myocardial Infarction and Revascularization in Emergency

时间窗: d30

次要结局

  • Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography(until the exit from the hospital and at d30.)
  • Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.(d30)
  • Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus(d30)

研究者

发起方
Hospital Avicenne
申办方类型
Other
责任方
Principal Investigator
主要研究者

FREDERIC LAPOSTOLLE

Frédéric Lapostolle

Hospital Avicenne

研究点 (1)

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