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

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.