Routine Upfront Abciximab Versus Standard Peri-Procedural Therapy in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock PRAGUE-7 Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Combined end-point death/reinfarction/stroke/TIMI-flow <3/EF <30% on day 30.
研究概览
简要总结
Outcome of patients with myocardial infarction complicated with cardiogenic shock is very poor. Although early mechanical revascularization has been demonstrated superior to conservative medical treatment, mortality range remains about 45-60%. Some medical registries have showed further therapeutic benefit by administration of glycoprotein (GP) IIb/IIIa inhibitors during PCI in patients with cardiogenic shock. However, there is no randomized study that supports this therapeutic strategy in these high risk patients.
Hypothesis:
GP IIb/IIIa inhibitors improve angiographic (TIMI-flow), echocardiographic (LV function) and clinical (combined end-point) outcomes in patients with myocardial infarction complicated with cardiogenic shock.
Study design:
Open "pseudorandomized" multicenter, phase IV clinical trial.
Anticipated findings:
The investigators anticipate to document better angiographic, echocardiographic and clinical outcome after upfront abciximab administration in comparison to standard periprocedural therapy in patients undergoing PCI for cardiogenic shock. This would be the first randomized clinical trial that could support this therapeutic strategy.
详细描述
Routine upfront abciximab versus standard peri-procedural therapy in patients undergoing percutaneous coronary intervention for cardiogenic shock PRAGUE-7 Trial.
Hypothesis:
GP IIb/IIIa inhibitors improve angiographic (TIMI-flow), echocardiographic (LV function) and clinical (combined end-point) outcomes in patients with myocardial infarction complicated with cardiogenic shock.
Study design:
Open "pseudorandomized" multicenter, phase IV clinical trial. The reason for "pseudorandomization" (i.e. randomization by even or odd date, when the PCI is performed) is ethical: it saves time, what is critical in this clinical setting. It does not delay treatment at all, while classical randomization in cardiogenic shock may sometimes delay treatment by up to 15 minutes and this is the main reason why randomized trials on shock are rarely able to enroll patients.
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
- •Acute myocardial infarction (ST elevation, ST depression or bundle branch block on ECG) with indication to urgent coronary angiography
- •Signs of cardiogenic shock including incompletely developed shock (at least one of the following must be present):
- •Hypotension (BP < 90mmHg) and HR > 90/min
- •Organ hypoperfusion-cold wett sweating skin and HR>90/min
- •Need of catecholamine support to maintain BP> 90/min
- •Klip II-III + systolic BP below 120 mmHg
- •Informed consent signed either by patient or his/her relative in case of diminished consciousness.
排除标准
- •Contraindications for the use of abciximab, either:
- •Hypersensitiveness to Reopro components
- •Active internal bleeding
- •History of stroke in last 2 years
- •Previous history (in last 2 month) of intracranial or intraspinal surgical intervention
- •Atrio-venous malformation or aneurysm
- •Known haemorrhagic diathesis or severe uncontrolled hypertension
- •History of thrombocytopenia
- •Therapy with oral anticoagulants (warfarin)
- •Cardiogenic shock caused by severe mitral regurgitation, rupture of free left ventricle wall or interventricular septum.
- •Pre-randomization heparin dose > 10 000 U during last 6 hours.
研究组 & 干预措施
1
Arm 1 - routine upfront administration of Reopro (Abciximab)
干预措施: Abciximab (Drug)
2
Reopro (Abciximab) only if needed - according to physician
干预措施: Abciximab (Drug)
结局指标
主要结局
Combined end-point death/reinfarction/stroke/TIMI-flow <3/EF <30% on day 30.
时间窗: 30 days
次要结局
- Left ventricular EF assessed by echocardiography on the day 30 (in deceased pts. EF assumed to be 0%)(30 days)
- Rate of major bleeding complication(30 days)
- Myocardial blush score after PCI(immediately after PCI)
- TIMI-flow after PCI(immediatelly after PCI)