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RESTEN-MP

Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries

Ensayo de Sarepta Therapeutics, Inc. en Coronary Artery Disease · Coronary Restenosis (del registro, en inglés).

Más ensayos de: Enfermedad coronaria.

Fase

Fase 2

Estado

Completado

Participantes

50

previstos

Centros

3

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2005.

Qué mide

Evaluate the potential efficacy of RESTEN-MP given intravenously upon confirmation of stent implantation and again at 24 hours post-stent implantation (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe process of re-narrowing of a coronary artery following a revascularization procedure such as angioplasty, begins at the time of the procedure. Restenosis has long been considered a major problem for effective long-term interventional success. This often results in repeated procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel. There is a substantial body of literature suggesting that local MYC protein production in the injured coronary artery is a major stimulus and potential cause of restenosis that appears after stent placement. This study is based upon the hypothesis that stopping MYC protein production in the vessel will help reduce restenosis (vessel re-narrowing). AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that interferes with MYC production. This study will evaluate the safety and potential effectiveness of RESTEN-MP to reduce in-stent restenosis following balloon angioplasty and stent placement. The post-dose follow-up period is up to six-months. RESTEN-MP is administered at the time a stent is successfully placed in a coronary artery, and again 24 hours later, via slow-push intravenous administration.

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Todos los de SRPT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00248066), actualizada en feb 2007.