title: Evaluation of ASPIRE trial: a Phase III pivotal registration trial, using intracoronary administration of Generx (Ad5FGF4) to treat patients with recurrent angina pectoris.
abstract: 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.
authors: St George's University of London, Cardiovascular Sciences Research Centre , Cranmer Terrace, London SW17 0RE UK jkaski@sgul.ac.uk.
authors: Juan Carlos
authors: JC
authors: Kaski
authors: Luciano
authors: L
authors: Consuegra-Sanchez
mesh_terms: D000256:Adenoviridae / Q000235:genetics*; D000787:Angina Pectoris / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D051519:Fibroblast Growth Factor 4 / Q000235:genetics*; D015316:Genetic Therapy; D005822:Genetic Vectors; D006801:Humans; D007269:Injections, Intra-Arterial; D008297:Male; D012107:Research Design; D055502:Secondary Prevention; D015899:Tomography, Emission-Computed, Single-Photon
chemical_list: C496445:FGF4 protein, human; D051519:Fibroblast Growth Factor 4