ANTHEM-TIMI 32 STUDY

Study of:
The purpose of this study is to see if the new, experimental anti-thrombotic medication rNAPc2 will be a safe and effective way to treat unstable angina or NSTEMI.

The purpose of this study is to see if the new, experimental anti-thrombotic medication rNAPc2 will be a safe and effective way to treat unstable angina or NSTEMI. Patients who qualify for the ANTHEM-TIMI 32 study have to be diagnosed by their doctor as having a blockage in an artery to their heart. The blockage may be new, leading to a diagnosis of NSTEMI, or ongoing chest pain that is relieved by rest, called unstable angina.

Patients who participate in the study will receive a dose of the study drug rNAPc2 or placebo by IV (intravenous) every 48 hours during the time that they are in the hospital (maximum of 4 doses). There will be several different doses of study drug.

rNAPc2 is based on the idea that the best way to stop more clots from forming inside heart arteries is to block Tissue Factor. Tissue Factor is the clotting protein that begins the clotting process. The study medication, rNAPc2 blocks Tissue Factor and may cause the clot to stop from forming. This would in turn allow blood and nutrients to be supplied to the heart.

Fpllow up consists of both clinic visits and phone calls. Clinic visits will entail a brief physical exam and blood tests. Study participants will have a clinic visit 7 days after the last dose of the study drug and 42 days after enrolling.

Telephone follow up will be made at 3 days, 14 days, 3 months and 6 months after the last dose of study drug.

Timothy D. Henry, MD, FACC

Theresa Happ, RN

For more information about this study or the Acute Coronary Syndromes Research program at the Minneapolis Heart Institute Foundation, please call Carol Stone at 612-863-9124.