跳至主要内容
临床试验/NCT00566891
NCT00566891已完成4 期

Safety of High-dose Tirofiban in Patient Undergoing Coronary Angioplasty.

S. Anna Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2007年12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
已完成
发起方
入组人数
2,000
试验地点
1
主要终点
Measure: all cause mortality

研究概览

简要总结

This single-centre study is intended to retrospectively check the safety of high-dose bolus of tirofiban in patients who underwent percutaneous angioplasty.

详细描述

Background The acute occlusion due to intrastent thrombosis represented a major event causing acute myocardial infarction, cardiac death and necessity for a new procedure or coronary by-pass intervention.

To avoid such complications different high anticoagulation regimens (heparin, antiplatelets agents and warfarin) were employed. Even if effective, such treatments were accompanied by a higher cost of side effects due to major bleeding (hemorrhagic stroke, retroperitoneal bleeding, gastrointestinal bleeding, need for transfusion, site access complications).

Pre-treatment with aspirin and ticlopidine was found to be very effective reducing intrastent acute thrombosis. Since several days of pre-treatment were required it became a limiting factor for interventional procedures forcing physicians to adopt a two-stage strategy that separated the diagnostic from interventional time increasing the hospital's costs and the patient's risks.

Beside that, high doses of heparin were still required during the procedures. The introduction of GP IIb/IIIa inhibitors was initially reserved to acute coronary syndrome, later it was shown how they reduce the composite incidence of death, myocardial infarction and the need for target vessel revascularization after percutaneous coronary intervention.

As major benefits arising from the use of those drugs, interventional procedures could be carried out at end of diagnostic procedure and major bleedings were reduced as require a lower heparin regimen.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing percutaneous coronary angioplasty

排除标准

  • Known allergy to tirofiban

研究组 & 干预措施

B

Placebo Comparator

Clopidogrel

干预措施: Clopidogrel (Drug)

A

Active Comparator

Tirofiban

干预措施: tirofiban (Drug)

结局指标

主要结局

Measure: all cause mortality

时间窗: one year

次要结局

  • measure: major bleeding(one year)

研究者

发起方
S. Anna Hospital
申办方类型
Other

研究点 (1)

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