Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI (RAPID-STEMI)
2026年6月8日 更新者：Dmitry Pevzner、National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
A Randomized Controlled Study of Reperfusion Strategies in Acute ST-segment Elevation Myocardial Infarction Under Conditions of Anticipated In-hospital Delay in Primary Percutaneous Coronary Intervention Strategy: the Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI (RAPID-STEMI)
This study aims at evaluating of the effectiveness of in-hospital thrombolysis for ST-segment elevation myocardial infarction in PCI centers under conditions of predicted in-hospital delay (>60 min after admission in PCI-center) of PCI.
Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 2-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
240
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Rimma Gulyan
- 电话号码：+79152284043
- 邮箱：rimmagulyan5@mail.ru
学习地点
-
-
Select A State
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Moscow、Select A State、俄罗斯、121552
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
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接触：
- Rimma Gulyan
- 邮箱：rimmagulyan5@mail.ru
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age equal or greater than 18 years
- "Symptom onset-randomization" time interval <12 hours
- Predicted "diagnosis-pPCI" time interval equal or greater than 120 minutes
- Predicted "admission-pPCI" time interval equal or greater than 60 minutes
- Informed consent received
Exclusion Criteria:
- Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：In-hospital thrombolysis in PCI-center
In-hospital thrombolysis with tenecteplase in case of predicted delayed pPCI (>60 min after admission in PCI-center).
Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention.
|
Single, weight-adjusted i.v.
bolus of tenecteplase in case of >60 min in-hospital delay in PCI center
Standard primary PCI
其他名称：
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有源比较器：Primary PCI in PCI-center
Standard primary PCI in case of predicted delayed pPCI (>60 min after admission in PCI-center).
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Standard primary PCI
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The number of observed patients with cardiovascular death, nonfatal stroke, and nonfatal AMI within 12 months for FAS.
大体时间：From enrollment to the end of follow-up (12 months).
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Participants achieved a response if they have cardiovascular death or nonfatal stroke, or nonfatal AMI at 12 months.
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From enrollment to the end of follow-up (12 months).
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Number of patients with all-cause mortality
大体时间：during hospitalization (assessed up to 10 days)
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during hospitalization (assessed up to 10 days)
|
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Number of patients with cardiovascular mortality
大体时间：during hospitalization (assessed up to 10 days)
|
during hospitalization (assessed up to 10 days)
|
|
Number of patients with non-fatal MI
大体时间：during hospitalization (assessed up to 10 days)
|
during hospitalization (assessed up to 10 days)
|
|
Number of patients with hemorrhagic stroke
大体时间：during hospitalization (assessed up to 10 days)
|
during hospitalization (assessed up to 10 days)
|
|
Number of patients with major bleeding according to the BARC scale (type 3-5)
大体时间：during hospitalization (assessed up to 10 days)
|
during hospitalization (assessed up to 10 days)
|
|
Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications )
大体时间：during hospitalization (assessed up to 10 days)
|
during hospitalization (assessed up to 10 days)
|
|
Number of patients with all-cause mortality
大体时间：12 months
|
12 months
|
|
Number of patients with cardiovascular mortality
大体时间：12 months
|
12 months
|
|
Number of patients with non-fatal MI
大体时间：12 months
|
12 months
|
|
Number of patients with hemorrhagic stroke
大体时间：12 months
|
12 months
|
|
Number of patients with major bleeding according to the BARC scale (type 3-5)
大体时间：12 months
|
12 months
|
|
Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications)
大体时间：12 months
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 研究主任：Dmitry Pevzner, Doctor of Medical Sciences、National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- 首席研究员：Rimma Gulyan、National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月20日
初级完成 (估计的)
2028年5月20日
研究完成 (估计的)
2029年5月20日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月8日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.