PREVAIL Trial
Study of:
BO-635 drug; sponsored by Chugai Pharmaceutical Co., Ltd.
Stents are small coil like tubes made of various types of metal materials. They are designed to keep blockages in the coronary arteries open. The drawback of stent placement is that a re-blockage (scar tissue) or restenosis can occur in 25% of the patients who receive a stent. There are various medical therapies to help prevent this from occurring. Currently, the treatment for restenosis is medications, radiation therapy, or coronary artery bypass surgery. We anticipate the FDA approval of drug eluding stents in the near future.
This trial was designed to assess the safety and effectiveness of the drug BO-635 for instent restenosis. Patients will be eligible for enrollment with successful stent placement in a new lesion in the coronary artery. This trial will be enrolling 600 patients at 45 sites. If the entry criteria is met, patients will be randomized to one of four treatment groups and receive six months of BO-635 medication or placebo. Follow up includes monthly clinic visits for an exam, ECG, blood work, urinalysis, and medication compliance. A six-month follow-up angiogram will be performed on patients that complete the study. A phone call at nine months will be completed to assess for the effectiveness of the drug.
- M. Nicholas Burke, MD
- John R. Lesser, MD, FACC
- Daniel Lips, MD, FACC
- James D. Madison, MD, FACC
- Michael R. Mooney, MD, FACC
- Wesley R. Pedersen, MD, FACC
- Anil K. Poulose, MD, FACC
- Jay H. Traverse, MD, FACC, FAHA
- Yale Wang, MD, FACC, FSCAI
For more information about the interventional cardiology research program at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Carol Stone at 612-863-9124.
|