Patients benefit from afib clinical trial at Backus
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Jeff Exley has been taking the blood-thinner Coumadin for 22 years to treat atrial fibrillation (commonly called "afib"). When he found out about a clinical trial for a new medication being conducted by Backus Hospital, he decided to participate.
"Hopefully I can help someone else through this process," he said.
Paula Provost, Research Protocol Coordinator at Backus, said the drug, being developed by Bristol-Myers Squibb, would offer an alternative to Coumadin for patients with afib who are at risk for stroke.
Afib is a heart rhythm problem that can lead to blood clots and am increased risk for stroke. According to the American Heart Association, more than 2 million Americans have afib, which can cause palpitations, shortness of breath, fatigue and stroke.
Mike Smith, PharmD, Clinical Coordinator of the Backus Department of Pharmacy, said if this anticoagulant is approved, it would not need the intensive monitoring wafarin (Coumadin) requires.
"It could save people time, money and the aggravation of constant monitoring," he said.
Blood levels must be carefully monitored because it can be very dangerous to be outside the normal range. Coumadin levels can be affected by diet, activity and interaction with other medications. Patients must be monitored at least monthly and if the levels are off, they may need to be monitored up to a few times a week.
When Mr. Exley was 23 years old, he was diagnosed with afib and it was not fixed by cardiac conversion, when the heart is shocked. It was unusual to be diagnosed at such a young age, and he said often he is unaware of his condition because he doesn't have symptoms such as shortness of breath or palpitations. He said Coumadin worked well for a number of years, but about three years ago it became harder to keep the levels steady and for three months straight he had to go in for weekly testing.
"This drug would be a lot less volatile, which would be good," he said.
Mr. Exley said he got involved to help others. He had always wanted to donate blood but can't because of his condition. The Norwich resident was enrolled in the study one year ago and continues to be followed.
Jean Williams, 75, of Griswold, has had afib for about five years. She was on Coumadin for about three years when she found out about this study and decided to participate.
"Everything is going well. I feel good," she said. "I hope this can help someone else down the road."
Mrs. Williams said she would have to have the blood work done in any case, so she was comfortable getting involved in the trial, which she started about a year ago.
This is a Phase III study, which uses a double-blind method to compare the investigational drug to Coumadin. This means neither the patient nor the doctor knows who is taking the investigational drug and who remains on Coumadin. Because of this, the monthly monitoring is continued. Patients are followed for three years. Costs for medication and monitoring are covered by the trial.
John Foley, MD, a cardiologist on the Backus Medical Staff, is the principal investigator on this trial. Jan Akus, MD, Medical Director of Backus' Anti-Coagulation Clinic, who specializes in geriatrics, and Mandeep Dhami, MD, an oncologist and hematologist on the Backus Medical Staff, also are involved in the study.
Patients who have afib or who have had it documented two times in the past year, with at least one risk factor for stroke, may qualify for the trial. Risk factors for stroke can include being older than 75, having a prior stroke or ischemic attack, having symptomatic congestive heart failure, diabetes or being treated for hypertension.
If you think you may qualify and would be interested in participating, call Ms. Provost at 892-6936.