516-739-4982

Closed Clinical Trials

Trial to Assess the Prevention of Thrombotic Events in Patients with History of Myocardial Infarction

The addition of ticagrelor to standard therapy (including low-dose aspirin) would reduce the incidence of major adverse cardiovascular events during long-term follow-up in patients with a history of MI.

Study Sponser
Astra Zeneca
Principal
Steven Shayani, MD
Investigator Sub
Andressa Borges, MD
Richard H. Smith, MD
Behzad Paimany, MD
Condition
Myocardial Infarction
Intervention Drug
Tricagalor and Brilinta
clinical-trial-box
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 on Obese and Overweight Subjects

To evaluate the long term treatment of the FDA approved medication, Belviq on cardiovascular outcomes.

Study Sponser
Eisai
Principal
Steven Shayani, MD
Investigator Sub
Behzad Paimany, MD
Condition
Overweight/Obese individuals with CVD
Intervention Drug
Belviq
clinical-trial-box
Study for reducing the risk of death, myocardial infarction, or stroke in patients with heart failure and significant coronary artery disease following an episode of decompensated heart failure

The Commander HF trial will evaluate the use of Xarelto in addition to standard HF therapy can reduce the risk of important clinical outcome events in patients with chronic HF and significant CAD. It is a Randomized, Double-Blind, Event-Drive, Multicenter study comparing the efficacy and safety of Rivaroxaban with Placebo.

Study Sponser
Janssen Pharmaceuticals
Principal
Steven Shayani, MD
Investigator Sub
Behzad Paimany, MD
Condition
Heart Failure & CAD
Intervention Drug
Xarelto
clinical-trial-box
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation

The Orbit Registry will evaluate the safety of oral anticoagulant agents in patients with atrial fibrillation.

Study Sponser
Janssen Scientific
Principal
Richard H, Smith, MD
Investigator Sub
Condition
New onset atrial fibrillation or patients with Afib who have been started on Pradaxa, Eliquis, Xarelto, or Savaysa within the last 3 months.
Intervention Drug
clinical-trial-box
Cardiovascular Inflammation Reduction Trial

While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of myocardial infarction, stroke, and cardiovascular death among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response.

Study Sponser
NIH & Astra Zeneca
Principal
Steven Shayani, MD
Investigator Sub
Andressa Borges, MD
Richard H. Smith, MD
Behzad Paimany, MD
Condition
Coronary Artery Disease
Intervention Drug
Methotrexate
clinical-trial-box
Prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP

This trial will test the hypothesis that canakinumab treatment of patients with MI at least one month prior to study entry and elevated hsCRP will prevent recurrent cardiovascular events.

Study Sponser
Novartis
Principal
Steven Shayani, MD
Investigator Sub
Christina Kennedy, RPA
Brian Paimany, MD
Condition
Post Myocardial Infarction
Intervention Drug
Canakinumab
clinical-trial-box
Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Diagnostic Examinations

Patients with stable angina or angina equivalent will be randomized to CCTA (Coronary CT angiography) or SPECT MPI (Nuclear Stress Test).

Study Sponser
American College of Radiology Imaging Network
Principal
Andressa Borges, MD
Investigator Sub
Steven Shayani, MD
Steven Zeldis, MD
Condition
Stable Angina
Intervention Drug
None
clinical-trial-box
A Study To Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhea

This study will evaluate the efficacy of repeat treatment with Rifaximin 550mg TID in subject with IBS-D who respond to initial treatment with Rifaximin 550mg TID.

Study Sponser
Salix Pharmaceuticals
Principal
David Gutman, MD
Investigator Sub
None
Condition
IBS-D
Intervention Drug
Rifaximin
clinical-trial-box
Global Registry on Long-Term Oral Anitithrombotic Treatment in Patients with Atrial Fibrillation

To evaluate how patient characteristics influence antithrombotic treatment choice and outcome events.

Study Sponser
Boehringer Ingelheim
Principal
Richard H. Smith, MD
Investigator Sub
None
Condition
Atrial Fibrillation
Intervention Drug
None
clinical-trial-box
Study to Assess the Effects of Dronedarone 400 mg BID for 12 Weeks on Atrial Fibrillation in Subjects with Permanent Pacemakers

This is a placebo-controlled, double-blind, randomized, multicenter study to assess AF burden and the effects of dronedarone 400mg BID versus placebo.

Study Sponser
Sanofi-Aventis
Principal
Steven Zeldis, MD
Investigator Sub
Steven Shayani, MD
Condition
Atrial Fibrillation
Intervention Drug
Dronedarone
clinical-trial-box
Prevention of Thrombotic Events in Patients with History of Myocardial Infarction

This is an event-driven, randomized, double-blind, placebo controlled, parallel group, international, multicentre study to assess the prevention of cardiovascular events with Ticagrelor compared to placebo on a background of ASA in patients with History of MI (1-3 years ago) and additional risk factors for atherothrombosis.

Study Sponser
Astra Zeneca
Principal
Steven Shayani, MD
Investigator Sub
Christina Kennedy, PA-C
Condition
Myocardial Infarction
Intervention Drug
Ticagrelor
clinical-trial-box
Evaluation of Efficacy and Safety of DU-176b (Edoxaban) Versus Warfarin In Subjects with Artial Fibrillation-Effective aNticoaGulation

This is an event driven, Phase 3, multi-national, multi-center, randomized, double-blind, double-dummy, parallel-group study to compare DU-176b to warfarin with regard to the composite primary endpoint of stroke and SEE.

Study Sponser
Daiichi Sankyo Pharma Development
Principal
Richard H. Smith, MD
Investigator Sub
Steven Shayani, MD
Christina Kennedy, PA-C
Condition
Atrial Fibrillation
Intervention Drug
DU-176b (Edoxaban)
clinical-trial-box
Extension of Dabigatran Treament in Patients with Atrial Fibrillation Who Completed the RE-LY Trial

This is an open-label extension study for patients who have participated in the RE-LY Trial and had been taking the medication Dabigatran.

Study Sponser
Boehringer Ingelehim Pharmaceuticals
Principal
Richard Smith, MD
Investigator Sub
Steven Shayani, MD
Matthew Moghadam
Condition
Atrial Fibrillation
Intervention Drug
Dabigatran
clinical-trial-box
Study for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, RAB ER 50 mg or ESO 40 mg for the treatment of moderate to severe erosive GERD.

Study Sponser
Eisai Medical Research Inc.
Principal
David Gutman, MD
Investigator Sub
Steven Shayani MD
Mattew Moghadam
Condition
Gastroesophageal Reflux Disease (GERD)
Intervention Drug
Rabeprazole sodium and Esomeprazole
clinical-trial-box
Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation

The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Study Sponser
Bristol-Myers Squibb
Principal
Richard Smith, MD
Investigator Sub
Steven Shayani MD
Steven Zeldis MD
Mattew Moghadam
Condition
Atrial Fibrillation
Atrial Flutter
Intervention Drug
Warfarin and Apixaban
clinical-trial-box
Efficacy and Safety Study to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Diseas

The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy.

Study Sponser
Cogentus Pharmaceuticals
Principal
George Yiachos, MD
Investigator Sub
Steven Shayani MD
Albert Schenone MD
David Gutman MD
Condition
Acute Coronary Syndrome
Myocardial Infarction
Coronary Artery Disease
Percutaneous Coronary Intervention
Intervention Drug
CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) and aspirin, Plavix (clopidogrel 75 mg) and aspirin
clinical-trial-box
Trial to Prevent Stroke or Systemic Embolism in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment

The purpose of this clinical research study is to learn if apixaban is more effective than Acetylsalicylic Acid (ASA) in preventing strokes and systemic embolisms associated with subjects who have atrial fibrillation. The safety of this treatment will also be studied.

Study Sponser
Bristol-Myers Squibb
Principal
Richard Smith, MD
Investigator Sub
Steven Zeldis, MD
Steven Shayani, MD
Condition
Atrial Fibrillation
Intervention Drug
Apixaban and Acetylsalicylic Acid (ASA)
clinical-trial-box
Investigational new drug program of Tegaserod 6 mg bid given orally in women adult patients with irritable bowel syndrome with constipation or with chronic idiopathic constipation

The purpose of this treatment is to provide tegaserod to eligible women adult patients who did not have satisfactory improvement of their irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) symptoms with other available treatment(s) and / or patients who had satisfactory improvement of their symptoms with prior tegaserod treatment for IBS-C or CIC.

Study Sponser
Novartis Pharmaceuticals Corporation
Principal
David Gutman, MD
Investigator Sub
None
Condition
Irritable Bowel Syndrome With Constipation Chronic Idiopathic Constipation
Intervention Drug
Tegaserod
clinical-trial-box
A 5-Year Registry Study of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn’s Disease (CD)

The primary objective of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.

Study Sponser
Abbott
Principal
David Gutman, MD
Investigator Sub
None
Condition
Crohn’s Disease
Intervention Drug
Adalimumab
clinical-trial-box
A Prospective Multi-Center Study for the Detection of Coronary Artery Disease With Cardiac Radionuclide Imaging

To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.

Study Sponser
GE Healthcare
Principal
Steven Shayani, MD
Investigator Sub
Steven Zeldis, MD
Condition
Coronary Artery Disease
Intervention Drug
Device: 64 Channel VCT
clinical-trial-box
Registry on Cardiac rhythm disorders: an international, observational, prospective survey assessing the control of Atrial Fibrillation

The purpose of this study is to collect information about the following: to see how well your AF is controlled, to compare the different choices of therapy for AF, and to see how AF responds to your treatment.

Study Sponser
Sanofi-Aventis
Principal
Richard Smith, MD
Investigator Sub
None
Condition
Atrial Fibrillation
Intervention Drug
None
clinical-trial-box
Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea

The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.

Study Sponser
AGI Therapeutics, Inc.
Principal
David Gutman, MD
Investigator Sub
None
Condition
Irritable Bowel Syndrome With Diarrhea
Intervention Drug
Rezular
clinical-trial-box
Registry of AT/AF Episodes in the CRM Device Population: RATE Registry

The purpose of this registry is to form a collection of information from various patients across the country and to observe the progress of their treatment.

Study Sponser
St. Jude Medical
Principal
George Juang, MD
Investigator Sub
None
Condition
Abnormal heart rhythm
Intervention Drug
None
clinical-trial-box
TREAT: The Crohn’s Therapy, Resource, Evaluation, and Assessment Tool Registry

The purpose of this study is to evaluate the long-term clinical, economic and humanistic outcomes of various treatment regimens, including infliximab, in Crohn’s disease in real world medical practice.

Study Sponser
Centocor, Inc.
Principal
David Gutman, MD
Investigator Sub
None
Condition
Crohn's Disease
Intervention Drug
None
clinical-trial-box
Pacing Evaluation – Atrial Support Study in Cardiac Resynchronization Therapy (PEGASUS CRT)

This study will look at different pacing modes (how a device is programmed to pace one’s heart), and how these modes may assist in one’s daily activities and how one is feeling.

Study Sponser
Boston Scientific Corporation
Principal
George Juang, MD
Investigator Sub
None
Condition
Heart Failure
Intervention Drug
Device: Cardiac Resynchronization Therapy
clinical-trial-box
Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision

The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen in-office for routine visits to check the status of their device.

Study Sponser
Medtronic Cardiac Rhythm Disease Management
Principal
George Juang, MD
Investigator Sub
None
Condition
Arrhythmia
Tachycardia
Atrial Fibrillation
Ventricular Fibrillation
Intervention Drug
Devices: Remote Management and In-Office Care
clinical-trial-box
Optim Lead insulation Material (OPTIMUM) Registry

The primary purpose of this registry is to produce a large database of information on patients implanted with an SJM Optim lead.

Study Sponser
St. Jude Medical
Principal
George Juang, MD
Investigator Sub
None
Condition
Patient Has a Standard Indication for a pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator.
Intervention Drug
None
clinical-trial-box
A Frequent Optimization Study Using the QuickOpt Method

The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with CRT-D device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-IEGM optimization methods).

Study Sponser
St. Jude Medical
Principal
George Juang, MD
Investigator Sub
None
Condition
Patient Has a Standard Indication for a CRT-D
Intervention Drug
Device: Optimization of atrio-ventricular (AV/PV) and inter-ventricular (V-V) delays
clinical-trial-box
Study to Compare Effects of Coreg CR and Coreg IR on Left Ventricular End Systolic Volume Index in Subjects With Stable Chronic Heart Failure

The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in improving heart function in subjects with stable chronic heart failure.

Study Sponser
GlaxoSmithKline
Principal
Albert Schenone, DO
Investigator Sub
Steven Shayani, MD
George Yiachos, MD
Jin Park, MD
Richard Smith, MD
Steven Zeldis, MD
Michael Gurfinkel, DO
Brian Paimany, MD
Steven Blumenthal, MD
George Juang, MD
Condition
Congestive Heart Failure
Intervention Drug
Omega-3-acid ethyl esters
clinical-trial-box
Parallel-Group Trial to Assess the Efficacy and Safety of Omacor for the Prevention of Recurrent, Symptomatic Atrial Fibrillation

The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.

Study Sponser
Reliant Pharmaceuticals
Principal
Richard Smith, MD
Investigator Sub
Steven Shayani, MD
Albert Schenone, DO
George Yiachos, MD
Jin Park, MD
Steven Zeldis, MD
Michael Gurfinkel, DO
Brian Paimany, MD
Steven Blumenthal, MD
George Juang, MD
Condition
Atrial Fibrillation
Intervention Drug
Omega-3-acid ethyl esters
clinical-trial-box
Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in patients with Atrial Fibrillation

The primary efficacy parameter is the combined endpoint of cardiovascular hospitalization and death. Secondary efficacy parameters are death of any cause, cardiovascular death, cardiovascular hospitalization and non-cardiovascular hospitalization.

Study Sponser
Sanofi-Aventis
Principal
Steven Zeldis, MD
Investigator Sub
Steven Shayani, MD
Condition
Atrial Fibrillation, Atrial Flutter
Intervention Drug
Dronedarone
clinical-trial-box
Study to Evaluate the Long-Term Safety of Renzapride 4 mg Once Daily in Women With Constipation-Predominant Irritable Bowel Syndrome

The main purpose of this study is to evaluate the long-term safety and tolerability of Renzapride at a dose of 4 mg taken once daily for 12 months in women with constipation-predominant irritable bowel syndrome (IBS-C).

Study Sponser
Alizyme
Principal
David Gutman, MD
Investigator Sub
Steven Shayani, MD
Condition
Constipation-Predominant Irritable Bowel Syndrome
Intervention Drug
Renzapride
clinical-trial-box
Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome

The purpose of the study is to investigate whether Renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients.

Study Sponser
Alizyme
Principal
David Gutman, MD
Investigator Sub
Steven Shayani, MD
Condition
Irritable Bowel Syndrome
Intervention Drug
Renzapride
clinical-trial-box
Blood Pressure Observational Study of Success

Outcomes data collection in Blood Pressure Success Zone program participants.

Study Sponser
Novartis
Principal
Novartis
Investigator Sub
None
Condition
Hypertension
Intervention Drug
None
clinical-trial-box
Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)

The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two methods of programming with respect to intrinsic activity.

Study Sponser
St. Jude Medical
Principal
Steven Shayani, MD
Investigator Sub
George Juang, MD
Condition
Arrhythmia
Intervention Drug
Device: Autointrinsic Conduction Search Algorithm
clinical-trial-box
Randomized Evaluation for the Prevention of Stroke and Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation

The primary objective of this trial is to demonstrate the efficacy and safety of Dabigatran Etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.

Study Sponser
Boehringer Ingelheim Pharmaceuticals
Principal
Richard Smith, MD
Investigator Sub
Steven Shayani, MD
Albert Schenone,
DO George Yiachos, MD
Jin Park, MD
Steven Zeldis, MD
Michael Gurfinkel, DO
Brian Paimany, MD
Steven Blumenthal, MD
Condition
Atrial Fibrillation
Intervention Drug
Dabigatran etexilate and Warfarin
clinical-trial-box
Assessing Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem Ipsum.

Study Sponser
Sanofi-Aventis
Principal
Steven Zeldis, MD
Investigator Sub
Steven Shayani, MD
Condition
Atrial Fibrillation
Intervention Drug
Dronedarone
clinical-trial-box
Evaluation of Patients with Stable Angina

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500 Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500

Study Sponser
Sanofi Aventis
Principal
Steven Zeldis, MD
Investigator Sub
Steven Shayani, MD
Condition
Atrial Fibrillation
Intervention Drug
Dronedarone
clinical-trial-box
Atrial Fibrillation: Focus on Effective Clinical treatment Strategies (AFFECTS) Registry

This is an observational registry used to gather real world data.

Study Sponser
Reliant Pharmaceuticals
Principal
Richard Smith, MD
Investigator Sub
Steven Shayani, MD
Condition
Atrial Fibrillation
Intervention Drug
None
clinical-trial-box
A Treat-to-Target of the Efficacy and Safety of Levemir®

This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care.

Study Sponser
Novo Nordisk, Inc.
Principal
Steven Shayani, MD
Investigator Sub
None
Condition
Diabetes Mellitus, Type 2
Intervention Drug
Insulin Detemir