At Orlando Heart Specialists we believe that today’s clinical trials provide the foundation for tomorrow’s clinical practice. Certified Physician Investigator Group (CPIG), our clinical research devision, opened in 2010 to assist our practice in providing access to cutting edge, academically focused “state of the art” care and technologies to our patients, who otherwise would not have access to potentially life saving medications outside of large academic institutions. We participate in clinical trials that are patient focused and provide access to important new drugs and devices that help improve quality of life and survival in patients with cardiovascular disease.
Interested patients have access to a variety of phase 3 clinical research trials that are aimed at understanding and improving upon existing treatments. Participation in clinical trials is always voluntary. Declining a research study will never impact the care provided to our patients in any way.
CPIG, is directed under the supervision and guidance of Dr. Babak Alex Vakili, who overseas the various trials and adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) which is universally recognized as a critical requirement to the conduct of research involving human subjects. Dr. Vakili is a member of the Association of Clinical Research Professionals (ACRP), and one of handful of nationally certified physician investigators in the United States. Dr. Vakili has over 50 publications in various prestigious medical journals.
Clinical Research Coordinator:
Megan Bodiford, our clinical research coordinator , is a graduate of Seminole State College where she earned an AS in Emergency Medical Services/Paramedics. Megan has been with Certified Physician Investigator Research Group since August of 2014 where she serves as our Clinical Coordinator. She has a been in the medical field for over 5 years but began her research journey in August of 2014. Megan is very focused and detail oriented and as such she flourishes in the research arena and patient care. Megan shares the belief that research will benefit our future endeavors in healthcare and is committed to providing only the best to our sponsors.
Ongoing Clinical Trials
1. Odyssey Outcomes Study: This study is evaluating the ability of investigational drug, called SAR236553, to lower LDL cholesterol and prevent heart attacks or strokes in people who have CHD and been recently hospitalized for a heart attack or unstable angina.
2. Merick Pfizer Trail B1521021: This study is to evaluate cardiovascular outcomes following treatment with Ertugliflozin in subjects with type 2 diabetes mellitus and established vascular disease.
3. Pfizer CV185-267: A phase IV trial to assess the effectivesness of Apixaban compared with usual care anticoagulation in subjects with non-valvular atrial fibrillation undergoing cardioversion.
4. Pfizer CV185-316 Augustus: This study id to evaluate the safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in patient with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
5. Palm Registry: The purpose of this registry is to learn more about doctor prescribed cholesterol lowering medications using the current and previous health guidelines. We also want to learn about barriers to disease prevention and knowledge of treatment goals among patients using cholesterol lowering medications and those that do not. We hope the information gained will help us to understand doctors’ treatment patterns, introduce new treatments and make current treatment guidelines clearer for cholesterol lowering therapies.
Completed Clinical Trials
Bayer BAY59-7939 – X-VERT Trial This study is to determine the effects and safety of using Xarelto to prevent cardiovascular events with patients newly diagnosed with atrial fibrillation scheduled for cardioversion.
Sanofi WAVE I: Real-world Study Evaluating Dronedarone Treatment Patterns and Outcomes in Patients with Atrial Fibrillation
Boehringer Ingelhiem 1160.129 GLORIA-AF This is a registry following various selected therapy choices for patients that have been recently diagnosed with atrial fibriallation. Those patients who are taking Pradaxa will continued to be monitored during a specified time frame.
Boehringer Ingelheim 1160.128 Pradaxa/GIS This study is to follow gastrointestinal symptoms for patients newly perscribed to Pradaxa. If a GIS symptom occurs, patients will be randomized to either take Pradaxa within 30 minutes of food or to take a proton-pump inhibitor.
Takeda Pharmaceuticals, Takada Examine Trial, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to evaluate Cardiovascular Outcomes Following Treatment with Aloglipton in Addition to Standard of Care in Subject with Diabetes and Acute Coronary Syndrome , 2012
Gilead Sciences, A phase 4, Randomized, Double-Blind, Placebo-Controlled, Cross-over Trial to Evaluate the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging. 2012