AIM-HIGH Clinical Study

Testing Niacin plus a Statin to Prevent Vascular Events

AIM-HIGH is a clinical trial sponsored by the National Heart, Lung and Blood Institute and KOS Pharmaceuticals. The study will test two different treatment strategies for correcting high cholesterol and preventing heart disease. Patients can be referred by their primary care physician or they can refer themselves to the study. All patients will take a drug to lower their LDL (“bad cholesterol”) with titration to NCEP goals. Approximately half of the patients will take an additional drug that raises levels of HDL and lowers levels of triglyceride.

To qualify, candidates must be 45 years or older with a history of cardiovascular disease. Participants also must have an imbalance of LDL and HDL plus elevated triglycerides. Participants will receive all study medications at no cost to them, as well as education on cardiovascular disease, nutrition and risk-factor reduction. They will be able to play an active role in improving their health while receiving expert medical care during the trial. Recruitment will last until the end of the year with five years of follow-up care included.

“As the only site participating in the Cleveland area, we are privileged to be a part of this important study. We look forward to working with patients and their primary care physicians as the study progresses,” said Laurie S. Sadler, M.D., medical director and site principal investigator of the Center for Vascular Heath. “This is a great opportunity for participants to improve cardiovascular care for themselves and future generations.”

Recent news about Pfizer pulling Torcetrapib off the research pipeline due to excess mortality and blood pressure increases makes both the ACCORD and AIM-HIGH trials extremely important in the search for additional risk reduction with agents known to enhance HDL levels and/or function.

To learn more, please call the Center for Vascular Health at 216.363.2732.

Inhaled Insulin Clinical Trial

Exciting New Insulin Delivery Method Offers Tremendous Convenience

The Center for Vascular Health is participating in a Novo Nordisk Pharmaceuticals-sponsored clinical trial that will investigate an exciting new way to deliver insulin – a pre-meal, inhaled insulin.

Participants must have a diagnosis of diabetes and be age 18 or older. Referrals may come from primary care physicians or individuals may self refer. Participants will be assigned to one of two arms of the study. One set of participants will be assigned to the new pre-meal inhaled insulin plus oral anti-diabetic medications group. The other group of participants will be assigned to oral anti-diabetic medications only.

Participants will benefit in several ways. All study-related supplies, medications, lab work, pulmonary function tests and chest x-rays will be provided at no cost. Also, participants will be given extra diabetic education and support to achieve the glycemic goals of the study.

This worldwide clinical trial is expected to include approximately 2,200 type-2 diabetes patients. The Center for Vascular Health will be taking referrals until June. The study will last six months for participants from the time they begin the trial.