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Evaluation of ASPIRE trial: A Phase III pivotal registration trial, using intracoronary administration of Generx (Ad5FGF4) to treat patients with recurrent angina pectoris

机译:ASPIRE试验的评估:一项III期关键性注册试验,使用冠状动脉内施用Generx(Ad5FGF4)治疗复发性心绞痛患者

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摘要

The ASPIRE study (a randomized, controlled, parallel group, multicenter study to evaluate the efficacy and safety of Ad5FGF-4 using adenosine single-photon emission computed tomography (SPECT) myocardial perfusion imaging in patients with stable angina pectoris) (ClinicalTrials.gov Identifier: NCT01550614) is a 100-patient, controlled, randomized, multicenter study conducted in six centers in Russia. This trial will assess the therapeutic efficacy of Generx (Ad5-FGF4) using rest and stress SPECT following a one-time, catheter-based administration. Adenovirus-based antianginal therapy represents an interesting option but the difficulties observed in the various trials carried out to date illustrate the complexity of the issue. Large and well-designed studies should be encouraged to provide definitive answers to this important research question.
机译:ASPIRE研究(一项随机,对照,平行分组,多中心研究,使用腺苷单光子发射计算机断层扫描(SPECT)心肌灌注显像评估Ad5FGF-4在稳定型心绞痛患者中的疗效和安全性)(ClinicalTrials.gov标识符:NCT01550614)是一项在俄罗斯的六个中心进行的100名患者,对照,随机,多中心研究。该试验将基于导管一次给药后,通过休息和压力SPECT评估Generx(Ad5-FGF4)的治疗效果。基于腺病毒的抗心绞痛疗法是一个有趣的选择,但是迄今为止进行的各种试验中观察到的困难说明了这一问题的复杂性。应鼓励进行大型且设计合理的研究,以为这一重要的研究问题提供明确的答案。

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