CVI to Participate in Two New Clinical Studies
The Research Department at the Cardiovascular Institute will participate in two new national studies which will provide valuable information to validate or improve current treatment protocols.
The CHAMP-HF observational study will examine treatment of heart failure and will help physicians and researchers better understand how different medications affect patients with this condition. This study will enroll up to 5,000 patients across the U.S. who have been diagnosed with heart failure and have a reduced ejection fraction (LVEF < 40% within the last 12 months). Ejection fraction is a measurement physicians use to determine how well the heart is pumping out blood. Patients who qualify and agree to participate will be asked to fill out questionnaires during their usual health care provider visits that occur during the study period (up to two years). Participants will receive payment for their study related expenses and can change their mind to opt out of the study at any time.
The Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) will assess the impact of copayment reduction by equalizing copayments for clopidogrel (Plavix) and tricagrelor (Brilinta). With financial factors removed from the equation, the ARTEMIS study will follow prescribing patterns, patient medication adherence and clinical outcomes for up to one year. This study is designed for patients 18 or older who have been hospitalized for heart attack (STEMI or NSTEMI) and treated with antiplatelet medications (P2Y12 receptor inhibitors). To qualify, patients must also carry US-based health coverage with prescription benefit. At enrollment, patients will receive a prescription voucher card to offset copayments for Plavix or Brilinta. The ARTEMIS study is a multicenter cluster-randomized trial, which means that that each participating site will be randomized as a control site or an interventional site. Sites in the interventional arm of the study will have the opportunity to offer enrolled patients the previously described voucher card to cover costs for the medications included in the study for 12 months following their discharge from the hospital for heart attack. Sites in the control arm will provide the usual standard of care.
Cardiologist Dr. Michael Morrow is the principal investigator at CVI for both of these studies however all CVI cardiologists can enroll patients. “We are grateful to have the opportunity to participate in this research,” says Dr. Morrow. “This gives us access to recent data collected from across the nation that can help us refine our treatment protocols and offer our patients the best, proven therapies currently available.”