Cardiology Clinical Trials

Please see below for cardiology clinical trials that are accepting patients as well as ongoing closed enrollment studies for which we conduct follow-up research.

If you are an interested patient, researcher or sponsor, please feel free to call us at (845) 483-6825 or email research@health-quest.org

Open Enrollment

Study Identifier: Dal-GenE Trial
Site Principal Investigator: Louis W. Kantaros, MD
Study Title: A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

Study Summary:  A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Study Identifier:TWILIGHT
Site Principal Investigator:  Louis W. Kantaros, MD
Study Title:  Ticagrelor with aspirin or ticagrelor alone in High Risk Patients after Coronary Intervention

Study Summary:  The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and forming a blood clot that could block blood flow to the heart. This study will look to determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events among high-risk patients who have had a placement of a cardiac stent  at least one drug-eluting stent. A patient is considered high-risk if they meet certain clinical and/or anatomic criteria.

Up to 9000 patients will be enrolled at the time of their cardiac catheterization and stent placement. Patients meeting randomization eligibility criteria at 3 months post enrollment will be randomized to either ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Follow-up clinic visits will be performed at 3 months, 9 months and 15 months post enrollment.

Study Identifier: CardioMEMS HF
Site Principal Investigator: James Lyons, MD
Study Title: CardioMEMSTM HF System Post Approval Study 

Study Summary: The purpose of this Post Approval Study (PAS) is to evaluate the use of the FDA approved CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting. The CardioMEMS HF system is not investigational and would be recommended by your cardiologist as standard of care to treat your heart failure if your symptoms meet the guidelines for its use. The CardioMEMS Heart failure (HF) monitoring system has been shown to significantly reduce HF hospital admissions and improve quality of life in NYHA class III patients. Heart failure (HF) is a clinical syndrome characterized by frequent hospitalization, poor quality of life, multiple comorbidities, high mortality and a complex therapeutic regimen. Affected individuals have a variety of symptoms such as dyspnea, fatigue, limited exercise tolerance, fluid retention, pulmonary congestion and peripheral edema. Patients suffer impairment in functional capacity and quality of life.

 

Study Identifier: PSR
Principal Investigator: Sankar Varanasi, MD
Study Title: Product Surveillance Registry

Study Summary: The purpose of this registry is to collect information over time about medical devices made by the company Medtronic, in patients who have had such a medical device placed in the body for a medical condition. A registry is a record of the experience of people with the device and its performance. The device is already approved by the U.S. FDA. This registry is not an experimental clinical study.

Study Identifier: ADAPT Response
Principal Investigator: Sankar Varanasi, MD
Study Title:  AdaptResponse Clinical Trial

Study Summary: The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

Closed Enrollment

Study Identifier: ARTEMIS
Site Principal Investigator: Louis W. Kantaros, MD 
Study Title: Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study 

Study Summary: This is a clinical trial that will assess the impact of copayment reduction by equalizing the copayment of clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication adherence, and clinical outcomes up to one year. Current medical management for patients who have had a myocardial infarction (MI) include a class of drugs known as antiplatelet therapy or P2Y12 inhibitors. Plavix (clopidogrel) and Brillanta (ticangrelor) are two of these drugs in this classification that are routinely prescribed following an MI. The study will also assess if reducing out-of-pocket patient costs for a P2Y12 receptor inhibitor will lead to improved medication adherence and thus a reduction in cardiovascular events.

Study Identifier: SPIRE 1 & SPIRE 2 
Site Principal Investigator: Daniel J. O’Dea, MD 
Study Title: The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects

Study Summary: Cardiovascular disease (CVD) due to atherosclerosis continues to be a leading cause of death. High serum lipid levels, and especially high low density lipoprotein cholesterol (LDL-C) levels, have been demonstrated to strongly and directly correlate with cardiovascular disease risks . This study is evaluating the investigational treatment of bococizumab, a class of drugs known as PCKS9 a monoclonial antibody, administered every two weeks by a subcutaneous injection to lower patients LDL-C while on background statin therapy. This study is indicated In patients at high risk of coronary events due to a history of CV disease (myocardial infarction, ischemic stroke, or arterial revascularization) or in high-risk patients without CV disease (diabetes mellitus, familial hypercholesterolemia, symptomatic peripheral vascular disease, or chronic kidney disease), bococizumab, when added to the existing standard of care, is indicated to reduce the risk of the following major CV events: CV death; Myocardial infarction; Stroke; and Hospitalization for unstable angina needing revascularization.

Study Identifier:THEMIS
Principal Investigator: Louis Kantaros
Study Title: A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus 

Study Summary: This study is being carried out to see if an investigational medication called ticagrelor is effective in preventing the occurrence of heart attack, stroke and/or death due to cardiovascular events in patients who have Type 2 diabetes. An investigational drug is a medication that is not yet approved by the U.S. FDA. 

Study Summary: The purpose of this study is to determine whether the investigational drug, alirocumab, might prevent future cardiovascular events like heart attacks or strokes in patients that have experienced an acute coronary event in the past 12 months. An investigational drug is a medication that is not yet approved by the U.S. FDA.

Study Identifier: CAMELLIA/TIMI 61 
Principal Investigator: Daniel O’Dea, MD
Study Title: A Study to Evaluate the Effect of Long-term Treatment with BELVIQ on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors

Study Summary:
The main purpose of this research study is to assess whether the drug, lorcaserin HCI (brand name BELVIQ) affects the risk of developing cardiovascular disease in men and women who meet the medical definition of obese or overweight and are at increased risk of heart disease or stroke. Lorcaserin HCI has been approved by the United States Food and Drug Administration (U.S. FDA) as an addition to a reduced-calorie diet and exercise for chronic weight management. The long-term effects on cardiovascular disease and prevention of Type 2 diabetes have not been studied; this research will study the effect of long-term use of lorcaserin HCI.

Study Identifier: DECLARE/TIMI 58
Principal Investigator: Louis Kantaros, MD
Study Title: Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

Study Summary: This study is being carried out to see if adding a drug called dapagliflozin to diabetes treatment is effective in reducing events such as heart attack, stroke and death from heart disease.

Study Identifier: ODYSSEY LTS13463
Principal Investigator: Louis Kantaros, MD
Study Title:  Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia

Study Summary:  To assess the long-term safety of alirocumab when added to lipid-lowering therapy in patients with heterozygous familial hypercholesterolemia (heFH).

Study Identifier: REVEAL
Principal Investigator: Daniel O’Dea, MD
Study Title: Randomized EValuation of the Effects of Anacetrapib Through Lipid-Modification

Study Summary: The purpose of this study is to see if improving levels of cholesterol (fatty material found in each cell of the body) with anacetrapib, an investigational drug, can help reduce the chance of having a heart attack, stroke or death (also known as vascular events). An investigational drug is a medication that is not yet approved by the U.S FDA.

Study Identifier: ODYSSESY Alternative
Principal Investigator: Daniel O’Dea, MD
Study Title: Study of Alirocumab in Patients with Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular Risk, Who are Intolerant to Statins

Study Summary:
The purpose of this study is to determine whether alirocumab is effective and safe compared to ezetimibe, in reducing cholesterol for patients with high cholesterol that have had side effects with the standard statin therapy and are at risk for cardiovascular disease.

Study Identifier: ODYSSEY Outcomes
Principal Investigator: Zubair Jafar, MD
Study Title: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment with Alirocumab

Study Summary: This study is designed to compare the effect of alirocumab with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia

Study Identifier: ACCELERATE
Principal Investigator: Zubair Jafar, MD
Study Title: A Study of Evacetrapib in High-Risk Vascular Disease

Study Summary: The purpose of this study is to demonstrate the safety and efficacy of evacitrapib in reducing cardiovascular death, heart attack, stroke or hospitalization for chest pain in patients who are at high risk for cardiovascular outcomes.

Study Identifier: RAID
Principal Investigator: Sankar Varanasi, MD
Study Title: Late Sodium Current Blockade in High-Risk ICD Patients

Study Summary: The purpose of the study is to see how effective the drug ranolazine with standard medications, is in reducing the risk of fast irregular heart beat rhythms (known as cardiac arrhythmias) and death in people with implantable cardioverter defibrillators. Ranolazine (known as Ranexa) has been approved by the U.S. FDA for the treatment of patients with chronic angina (pain or discomfort in the chest, jaw, shoulder, back or arm that keeps coming back), a symptom of a heart problem called coronary heart disease. It has not been approved for the prevention and treatment of irregular heart beat rhythm. Its use in this study is for research purposes only.

Ian Portelli PhD BCDM PNP MSc
AVP, Medical Research & Operations for Health Quest
Director, Trauma Program Vassar Brothers Medical Center
Email: iportelli@health-quest.org

William Rausch, ScB
Clinical Research Compliance Manager
Email: wrausch1@health-quest.org

Carissa Sharp, BS
Clinical Research Operations Coordinator
Email:csharp1@health-quest.org

Lauren Studer, MA
Clinical Research Coordinator
lstuder@health-quest.org

Daniel Lackaye, MA
Clinical Research Coordinator
Email: dlackaye@health-quest.org

Cindy Miller, BA
Clinical Research Coordinator
E-mail: Cmiller6@health-quest.org

Trisha Burrello, MS, CCRC
Clinical Research Coordinator
E-mail: tburrell@health-quest.org

Events

We currently have no Cardiology Clinical Trials events. Please check the latest Health Quest events.

Whether you are a patient, researcher or sponsor interested in our clinical trials, we’re happy to talk with you and answer any questions.
Please contact us at:

Division of Clinical Research
Vassar Brothers Medical Center
28 Reade Place, 1st Floor
Poughkeepsie, NY 12601

Phone: (845) 483-6825
Fax: (845) 483-6503
Email: research@health-quest.org