Clinical Trial Studies Cholesterol Medicine and Heart Disease

CINCINNATI—A new clinical trial at UC Health University Hospital will help evaluate the effects of a cholesterol medication on patients at risk for heart disease.

Imran Arif, MD, UC Health cardiologist and main investigator on the study locally, says this multi-center trial may help reduce cardiovascular death and further disease development in those who have already experienced symptoms of heart disease.

"The study drug is thought to raise good cholesterol and may help physicians discover an effective treatment for cardiac patients to prevent cardiac disease-related death,” he says.

The study, which is double-blind, randomized and placebo-controlled—meaning neither patient nor doctor knows if a placebo or actual medication is being administered to participants—will take place over the course of two and a half years.

Patients who have been hospitalized with acute coronary syndrome—an umbrella term used to describe any group of symptoms compatible with heart attack or chest pain due to insufficient blood supply to the heart muscle that leads to heart disease—will be selected to take part in this trial.

"Eligible patients will be stabilized for the first four to 12 weeks and will then be given either 600 mg of dalcetrapib, a cholesterol medication that raises levels of HDL (good cholesterol), or a placebo,” he says, adding that researchers are hoping to look at 1,600 cases locally. "Patients will visit the clinic at the four week and three month periods and then every three months during the first year.”

He says that after the first year, patients will be asked to come to the clinic every four months for safety assessments.

"We are trying to discover the safety of dalectapib in long-term care and to see if this medication has a true effect on the lipid metabolism and markers related to heart inflammation,” he says. "This has the potential to be a cost-effective, efficient way to prevent progression of heart disease in patients, improving their quality of life.”

This study is being sponsored by Roche Pharmaceuticals, Inc., and is part of a larger clinical trial that is looking at approximately 15,600 subjects. Arif cites no conflict of interest and does not receive honoraria from the manufacturers of dalcetrapib.