The Carolina Regional Heart Center
The following clinical trials are in progress for cardiac care. If you are interested in participating in a trial, please discuss the specific trial with your physician and ask him to contact the local PI on your behalf.
1.“ACUITY” --- A study comparing the effectiveness of type I drugs, i.e. enoxaparin, to the study drug bivalirudin, for the prevention of blood clots and bleeding.
Industry sponsored: The Medicines Company, Parsippany, NJ
Local PI: Barry Cheek, MD
Local IRB approval: October 2003
Status: The study is closed to enrollment
2.“CHAMPION PCI” --- A study comparing the effectiveness of the experimental drug Cangrelor to the standard treatment of Plavix in people who are having a procedure to treat the blood vessels in the heart.
Industry sponsored: The Medicines Company, Parsippany, NJ
Local PI: Steven Rohrbeck, MD
Local IRB approval: October 2006
Status: The study is open to enrollment
3.“CORAL” --- A study comparing the safety and effectiveness of stenting plus medical management versus medical management alone, in treating renal artery stenosis in hypertensive patients.
A cooperative study under the primary direction of The National Heart, Lung and Blood Institute.
Local PI: Barry Cheek, MD
Local IRB approval: February 2005
Status: The study is open to enrollment
4. “CURRENT/OASIS 7” --- A study comparing whether a higher dose of Plavix, when used with aspirin, will lead to a further decrease in the risk of ischemic complications in cardiac patients who have undergone a procedure called a PCI. The study will also compare two different doses of aspirin to evaluate if the higher dose will lead to a decrease in the risk of ischemic complications in those same cardiac patients compared to a lower aspirin dose.
Industry sponsored: Sanofi-Aventis, U.S. based in Bridgewater, NJ
Local PI: Barry Cheek, MD
Local IRB approval: October 2006
Status: The study is open to enrollment
5. “DXV 405” --- A study to evaluate and compare the effects on kidney function of two contrast medias in patients with impaired renal function and diabetes mellitus undergoing angiography with or without percutaneous coronary intervention (PCI).
Industry sponsored: GE Healthcare Ltd., Oslo, Norway
Local PI: Steven Rohrbeck, MD
Local IRB approval: July 2005
Status: The study is closed to enrollment
6.“IMPROVE-IT” --- A study comparing two drugs, Vytorin and Zocor, to assess their ability to lower LDL-C levels.
Industry sponsored: Schering-Plough Research Institute, Kenilworth, NJ
Local PI: Steven Rohrbeck, MD
Local IRB approval: November 2005
Status: The study is open to enrollment
7.“InSync Post-Market Registry” --- A data collection study, (a registry), to evaluate the performance of three FDA-approved devices used in the treatment of heart failure.
Industry sponsored: Medtronic, St. Paul, MN
Local PI: Zan Tyson, MD
Local IRB approval: February 2007
Status: The study is open to enrollment
8.“MAPP” --- A substudy of MASTER, to determine if a new blood test can be developed that will allow doctors to identify patients who are at high risk of dying suddenly from very rapid heart rhythms before the rhythms occur.
Industry sponsored: Medtronic, St. Paul, MN
Local PI: Zan Tyson, MD
Local IRB approval: August 2005
Status: The study is closed to enrollment
9.“MASTER” --- A study to determine the usefulness of T-wave alternans testing in patients that have had a heart attack and have decreased pumping ability of the lower chamber of the heart. The study will also evaluate how T-wave alternans testing is used by doctors to treat patients with such medical conditions.
Industry sponsored: Medtronic, Minneapolis, MN
Local PI: Zan Tyson, MD
Local IRB approval: August 2003
Status: The study is closed to enrollment
10.“PLATO” --- A study comparing whether the experimental drug AZD6140 is more effective than Plavix in stopping the formation of new blood clots.
Industry sponsored: AstraZeneca AB, Sodertalje, Sweden
Local PI: Barry Cheek, MD
Local IRB approval: October 2006
Status: The study is open to enrollment
11.“STENT” --- A data collection study designed to collect information on the successes, complications and long-term results of new interventional cardiovascular devices.
Sponsor: The R. Stewart Dickson Institute for Health Studies, (RSDIHS) at Carolinas Medical Center, Charlotte, NC
Local PI: Barry Cheek, MD
Local IRB approval: December 2002
Status: The study is open to enrollment
12.“TRITON” --- A drug study comparing Plavix to the investigational drug CS-747 to determine if CS-747 can help reduce death, future heart attack, or stroke in someone who has had a heart attack and needs or may need a balloon angioplasty procedure called a primary percutaneous coronary intervention (PCI); and to determine the safety and side effects of CS-747.
Industry sponsored: Eli Lily and Company, Indianapolis, IN
Local PI: Barry Cheek, MD
Local IRB approval: November 2004
Status: The study is closed to enrollment