Overview of the Research Program at Desert Cardiology
The physicians of Desert Cardiology have been actively involved in conducting clinical research since the mid 1990's. The program has grown exponentially since its inception and we are highly sought after as a research site by pharmaceutical, medical device and biotechnology companies. DCC has also participated in several prestigious NIH-funded studies. Participation in research offers advantages to patients, physicians, and the community. Our cardiologists are knowledgeable of and able to offer the most cutting edge therapeutic and diagnostic treatment options.
A number of the clinical staff at DCC function as coordinators for studies. Our Nurse-Practitioners, Physician Assistants, nurses from the Heart Failure clinic, and staff from clinical areas throughout the hospital have all participated in conducting trials. Desert Cardiology has employed at least one full-time Research Coordinator for the past 6 years as well. Every physician who participates as an Investigator is required to complete an annual certification in the Protection of Human Subjects and have knowledge of Good Clinical Practice and the ICH guidelines.
Our patients may be requested to participate in an ongoing study if their DCC physician feels it is in their best interest and if the inclusion/exclusion criteria for the study is met. The physicians and research staff are available to explain the study and provide answers to your study questions anytime.
All studies must be approved by the Institutional Review Board of Eisenhower Medial Center and follow HIPAA regulations for privacy. Participation is voluntary.
Attached is a brief overview of some of the studies we have participated in over the last 5 years. It encompasses the range of cardiology, including the Electrophysiology lab, Cardiac Catheterization lab, ER, Heart Failure Clinic, Out-patient Studies and Health Data Registries.
STUDIES AT DESERT CARDIOLOGY
CURRENTLY ENROLLING
ARISTOTLE
Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation
OBJECTIVE: To determine if apixaban is non-inferior to warfarin (INR target range 2.0 - 3.0) in the combined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, in subjects with AF and at least one additional risk factor for stroke.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: Bristol-Myers Squibb
CONNECT
Clinical Evaluation of remote Notification to Reduce Time to Clinical Decision
OBJECTIVE: To demonstrate that the remote management system reduces the time to clinical decision for arrhythmias, cardiovascular disease progression and system issues compared to subjects receiving only in-office care.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: Medtronic
CORDIS ELITE
A Prospective Single Blind, Randomized, Multi-Center, Study Comparing the CYPER ELITE to the CYPER Bx VELOCITY Sirolimus-Eluting Stent Systems
OBJECTIVE: To show similar safety and effectiveness of two different types of drug-coated coronary artery stents for heart disease, specifically coronary artery disease.
PRIMARY INVESTIGATOR: Puneet K. Khanna, MD
CO-INVESTIGATORS: Barry T. Hackshaw, MD - Khoi M. Le, MD
SPONSOR: CORDIS
ECGopt
Electrocardiography for Optimization of Atrio-Ventricular and Inter-Ventricular Delays
OBJECTIVE: To find simple electrocardiographic methods for automatic determination of the optimal AVD and VVD for Bi-ventricular stimulation in both atrial sensed and paced modes.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: Medtronic
FREEDOM
A Frequent Optimization Study Using the QuickOpt Method
OBJECTIVE: To demonstrate that frequent AV/PV and V-V delay optimization using QuickOpt in patients with CRT-D device results in improved clinical response over standard of care (empiric programming or one-time optimizations using any non-IEGM optimization methods).
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: St. Jude Medical
PEGASUS CRT
Atrial Support Study in Cardiac Resynchronization Therapy
OBJECTIVE: Randomized, prospective, single blind, three-arm study that will assess the effect of a CRT-D device programmed to DDD-70 or DDDR-40 compared to a CRT-D device programmed to DDD-40. Clinical efficacy will be assessed by evaluating the effect of pacing mode on a clinical composite score. Other endpoints will be changes in clinical outcomes such as quality of life, physical activity, atrial arrhythmia burden, medications and programming changes, crossovers.
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Guidant
REPLACE
Estimate all-cause complication rates for patients undergoing a generator replacement.
OBJECTIVE: To accurately estimate the all-cause complication rates at 6 months in patients undergoing generator replacement.
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Biotronik
RESPECT
Reducing Episodes of Atrial Fibrillation by Septal Pacing Efficacy Confirmation Trial
OBJECTIVE: To confirm pacing effectiveness of the AT-500 (pacemaker) in reducing symptoms of atrial tachycardia and atrial fibrillation.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATORS: Leon A. Feldman, MD
Damon E. Kelsay, MD
SPONSOR: Medtronic
RIGHT
Assess time to first inappropriate shock from ICDs.
OBJECTIVE: Assess and compare the time to first inappropriate rhythm classification leading to all therapies, esp. shock, using Guidant (Rhythm ID) and Medtronic (Enhanced PR Logic and Wavelet) ICDs. Assess and compare the positive predictive value (PPV) of VT/VF discrimination algorithms found in Guidant and Medtronic ICDs.
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Guidant
ONGOING STUDIES AT DESERT CARDIOLOGY
ENROLLMENT CLOSED - FOLLOW-UP PHASE
AF-CHF
An International Study Evaluating the Value of a Therapeutic Strategy to Restore and Maintain Sinus Rhythm in Patients with Atrial Fibrillation and Congestive Heart Failure vs. a Strategy of Rate Control Alone
OBJECTIVE: For patients who have symptomatic heart failure and atrial fibrillation. To evaluate rhythm control of atrial fibrillation using antiarrhythmic drug therapy vs. rate control using beta blockers and/or digoxin drug therapy.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Canadian Institutes of Health Research-Canadian NIH/Montreal Heart Institutes
ARRIVE 2
Registry with TAXUS Express 2 Paclitaxel-Eluting Stent
OBJECTIVE: To compile safety surveillance and clinical outcomes data (restenosis of stent, myocardial infarction) when an Express 2 drug coated stent is used for intervention during a cardiac angiogram.
PRIMARY INVESTIGATOR: Puneet K. Khanna, MD
CO-INVESTIGATORS: Barry T. Hackshaw, MD
Khoi M. Le, MD
SPONSOR: Boston Scientific
ATHENA
Anti-arrhythmic medication, Dronedarone, similar to Amiodarone, to control atrial fibrillation/atrial flutter.
OBJECTIVE: A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400mg bid for the prevention of CV hospitalization or death from any cause in pts. with AF/AFL.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: Sanofi-Aventis
BROADWING
Registry to collect biological material from peripheral vascular procedures.
OBJECTIVE: The primary objectives of the registry are to:
1. Collect biological material (waste plaque and blood) such that the
Sponsor and its researchers and licensees may study peripheral and cardiovascular disease and other related diseases or conditions and develop new diagnostics, drugs and therapies for treating those conditions.
2. Correlate outcomes data with gene expression, protein, and other data.
The secondary objectives of the registry are to:
1. Record the demographics, risk factors, clinical presentation, and other diagnostic and therapeutic information on patients who undergo plaque excision with the SilverHawk system;
2. Document treatment strategies of patients who undergo plaque excision;
3. Collect outcomes data on patients who undergo plaque excision, as well as information on repeat plaque excision procedures, and other adjunctive procedures.
PRIMARY INVESTIGATOR: Puneet K. Khanna, MD
CO-INVESTIGATOR: Khoi M. Le, MD
SPONSOR: FoxHollow
DECODE
Decompensation Detection Study - An observational study that will collect information from CRT-D patients that have been prescribed to the Guidant LATITUDE system.
OBJECTIVE: To gather data and to develop an algorithm that can predict or detect heart failure decompensation events or detect an elevated level of risk for these events.
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Guidant
EASYTRAK 3 Downsize
Guidant EASYTRAK 3 Downsize Lead, consisting of Lead Models 4591, 4592 and 4593, will be evaluated in this clinical investigation.
OBJECTIVE: To evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead, by demonstrating an acceptable lead-related complication free rate and appropriate pacing and sensing.
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Guidant
OMNI
Post-market observational study of EnRhythm Pacemaker, Intrinsic and EnTrust ICDs and InSync Sentry CRT-D.
OBJECTIVE: To characterize therapy and diagnostic utilization in pts. implanted with study devices and to describe ICD therapy utilization for life threatening arrhythmias in primary and secondary prevention study participants.
Specific requirements regarding device programming or study participant treatment are not mandated in this study.
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Medtronic
STUDIES COMPLETED - 2007
ASSIST
Atrial tachyarrhythmia Suppression Strategy in ICD Subjects Trial
OBJECTIVE: To evaluate clinical benefits and outcomes of atrial fibrillation (AF) suppression pacing in patients with an ICD indication by using an ICD suppression algorithm (increased pacing before AF starts).
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: St. Jude Medical
EASYTRAK EPI
Guidant's EASYTRAK EPI bipolar pace/sense lead is an epicardial lead, which is inserted throught the ventricular epicardial surface of the heart and paces the myocardium. It provides chronic, dual-electrode pacing and sensing. The lead has an open lumen design with an IS-1 or LV-1 dipoar connector, dual IROX-coated (iridium oxide) electrodes. And is sterid eluting distal to each electrode. The lead is anchored to the epicardium with a T-bar suture.
OBJECTIVE: To demonstrate safety and effectiveness of the lead. The data collected will be used for submissions to the FDA to acquire market-release approval.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
Surin N. Mitruka, MD
Joseph W. Wilson, MD
SPONSOR: Guidant
LEAP
Lower Extremity Atherosclerotic Plaque Excision
OBJECTIVE: This is multi-center, randomized, double-blind, placebo-controlled, 6-week study. The study consists of 3 separate sub-studies in which patients undergoing bilateral lower extremity peripheral artery atherectomy will receive one of three drugs known to have beneficial effect on the risk of cardiovascular disease.Following successful completion of a 1- to 2-week placebo run-in period, patients with bilateral symptomatic PAD requiring bilateral revascularization will undergo a unilateral atherectomy using the SilverHawk™ device. Based on medical history and concomitant medications, patients will be assigned to one of three treatment groups (simvastatin, losartan, or pioglitazone), and will be randomly allocated to the active drug or matching placebo for a period of 6 weeks. Patients will then undergo repeat peripheral atherectomy on the contralateral leg. A telephone follow-up will be made at Week 8. Blood for gene expression profiling and plasma/serum for circulating biomarkers will be taken at Week 0 and 6.
PRIMARY INVESTIGATOR: Puneet K. Khanna, MD
CO-INVESTIGATOR: Khoi M. Le, MD
SPONSOR: FoxHollow
ONGOING STUDIES AT DESERT CARDIOLOGY
ENROLLMENT CLOSED - FOLLOW-UP PHASE
IMPACT A2a
OBJECTIVE: International blinded and randomized study for BMS068645 VS. Adenosine SPECT. Study medication is similar to Adenosin used in nuclear stress test, previous studies have proven similar results with fewer side effects.
PRIMARY INVESTIGATOR: Barry T. Hackshaw, MD
CO-INVESTIGATORS: Eric M. Sontz, MD
Philip J. Patel, MD
Philip J. Shaver, MD
SPONSOR: Bristol - Myers Squibb
LEAD CONNECTOR IMAGING
OBJECTIVE: Collect high quality medical images and measure lead connector shape change during arm motion, for use in improving cardiac lead design and testing capability.
PRINCIPAL INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Medtronic
REFLEX
ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance
OBJECTIVE: To evaluate ENDOTAK RELIANCE G defibrillator leads (used with ICDs) with Gore ePTFE-covered coils. Compare this lead to similar leads manufactured by other companies for impulse transmission and handling during implant. The GORE covering prevents tissue ingrowth and attachment for the ease of removal in the unlikely event of failure.
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Guidant
RESTORE
Registry of Cardiac Resynchronization Therapy
OBJECTIVE: Registry of the effectiveness of Cardiac Resynchronization Therapy (CRT) in patients with heart failure induced conduction disturbances.
PRIMARY INVESTIGATOR: Barry T. Hackshaw, MD
SPONSOR: Medtronic
ADHERE
Acute Decompensated Heart Failure Registry
OBJECTIVE: Registry of the management of patients treated in the hospital for decompensated heart failure.
PRIMARY INVESTIGATOR: Puneet K. Khanna, MD
SPONSOR: Scios
7 STUDIES COMPLETED - 2004
HRV
Heart rate variability
OBJECTIVE: Registry to evaluate how HRV monitor diagnostics change after Cardiac Resynchronization Therapy (CRT), after implant of a bi-ventricular devise.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
Co-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: Guidant
3-D LEAD RECONSTRUCTION POST IMPLANT
Viewing leads for future design changes.
OBJECTIVE: Series of fluoroscopy imaging to help in future lead design.
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Medtronic
VAST
Ventricular Arrhythmia Suppression Trial
OBJECTIVE: Registry to determine the rate smoothing feature in Guidant ICDs: Prizm and Vitality, that reduces ventricular tachyarrhythmias.
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Guidant
MATRIX
Femoral artery closure devise
OBJECTIVE: To evaluate the safety and effectiveness of the Matrix VSG System to achieve closure of femoral artery access sites in patients undergoing diagnostic or interventional vascular procedures.
PRIMARY INVESTIGATOR: Puneet K. Khanna, MD
SPONSOR: Access Closure
TNT
An International Study Treating to New Targets: The Effect of LDL-Cholesterol Lowering Beyond Currently Recommended Minimum Targets on Coronary Artery Disease (CAD) Recurrence in Patients with pre-existing CAD.
OBJECTIVE: To evaluate if there is a difference in recurrence of CAD between two different doses groups receiving Lipitor, a high dose (80mg) and a low dose (10mg).
PRIMARY INVESTIGATOR: Eric M. Sontz, MD
SPONSOR: Pfizer/Parke-Davis
SYNERGY
Heparin Treatment for Patients Presenting with Acute Coronary Syndromes
OBJECTIVE: To evaluate the efficacy and safety between Enoxaparin (a low molecular heparin) and unfractionated heparin in high risk patients who present with unstable angina or myocardial infarction.
PRIMARY INVESTIGATOR: Barry T. Hackshaw, MD
SPONSOR: Aventis Pharmaceuticals
SERF
Synergistic Effects of Risk Factors for Sudden Cardiac Death
OBJECTIVE: To evaluate how combinations of risk factors may affect the likelihood that a newly implanted ICD patient will experience an episode of ventricular tachycardia or ventricular fibrillation. Factors assessed: prior MI, history of fainting, history of atrial fibrillation, left ventricular dysfunction, history of non-sustained ventricular tachycardia. Also to measure the frequency of spontaneous ventricular arrhythmias during the 24-month follow up.
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Guidant
7 STUDIES COMPLETED - 2003
ADVANCENT
Registry to gather data on patients with left ventricular dysfunction (LVD) whose ejection fraction is less than 40%
OBJECTIVE: To study LVD patients in real-world setting, provide a mechanism to evaluate and improve the application of therapies supported by evidence-based medicine. Therapies include: beta-blockers, ACE inhibitors, lipid-lowering agents, ICDs and CRT-D (cardiac resynchronization therapy).
PRIMARY INVESTIGATOR: Leon A. Feldman, MD
CO-INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: Guidant
ASPECT
AT-500 Pacing Protocol to Prevent Atrial Fibrillation
OBJECTIVE: New strategies in pacing technology and surgical techniques to improve the quality of life in patients with atrial fibrillation.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: Medtronic
OVERDRIVE DUAL-CHAMBER PACING TO REDUCE THE INCIDENCE OF VENTRICULAR TACHYARRHYTHMIAS WITH THE GUIDANT/CPI VENTAK AV AICD SYSTEM
OBJECTIVE: To evaluate whether dual chamber AV sequential pacing with complete ventricular capture (overdrive dual-chamber pacing) reduced the incidence of sustained and non-sustained ventricular tachyarrhythmias in patients considered at high risk for ventricular tachyarrhythmias.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: Guidant
COMPARISON OF DUAL- AND SINGLE-CHAMBER THERAPY RESPONSIVENESS USING THE GUIDANT VENTAK AICD FAMILY
OBJECTIVE: Compare the presence of clinically inappropriate therapies for tachyarrhythmias in patients who received wither a single- or dual-chamber implantable cardioverter defibrillator.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: Guidant
CHARM
An International Study Candesartan Cilexitil in Heart Failure Assessment of Reduction in Mortality and Mordibity
OBJECTIVE: To assess the effectiveness of Candesartan (antihypertensive) in the treatment of congestive heart failure patients.
PRIMARY INVESTIGATOR: Merle R. Bolton, MD
SPONSOR: AstraZeneca
PROVE IT - TIMI 22
Pravastatin or Atorvastatin Evaluation and Infection Therapy
OBJECTIVE: Compare the effectiveness of Pravastatin to Atorvastatin, two lipid lowering agents, in reducing the risk of recurrent cardiovascular events in patients who have been hospitalized for myocardial infarction within the previous ten days. It also explored the role of infection in cardiovascular disease by evaluating the effectiveness of Gatifloxacin (anti-infective) in reducing the risk of recurrent cardiovascular events in subjects hospitalized for a myocardial infarction within the previous ten days.
PRIMARY INVESTIGATOR: Barry T. Hackshaw, MD
SPONSOR: Bristol-Myers Squibb Co.
FIRE
Filter Wire During Transluminal Intervention of High Risk Saphenous Vein Grafts
OBJECTIVE: To evaluate the safety and performance of the FilterWire EZ Embolic Protection System during angioplasty/stenting of saphenous vein grafts.
PRIMARY INVESTIGATOR: Puneet K. Khanna, MD
SPONSOR: Boston Scientific/EPI
8 STUDIES COMPLETED - 2002
AFFIRM
Atrial Fibrillation Follow-Up Investigation in Rhythm Management
OBJECTIVE: Compare 2 long-term treatment strategies for atrial fibrillation (AF)in patients who had a high risk of stroke or death. Patients were randomized to either a rhythm-control strategy of cardioversion and treatment with antiarrhythmic drugs to maintain sinus rhythm OR a rate-control strategy that allowed AF to persist while the ventricular response to AF was controlled.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: National Heart, Lung & Blood Institute
REPLACE 1
Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events, Part 1
REPLACE 2
Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events, Part 2
OBJECTIVE: Demonstrate the efficacy of Angiomax (anticoagulant) used in percutaneous coronary intervention when combined with Glycoprotein IIb/IIIa inhibitors (antiplatelet agent).
PRIMARY INVESTIGATOR: Khoi M. Le, MD
SPONSOR: The Medicines Company
MAGIC
Study of Intravenous Magnesium for Acute Myocardial Infarction
OBJECTIVE: Examine the efficacy of intravenous magnesium to improve survival in patients after an acute myocardial infarction.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
SPONSOR: National Institute of Health
FUSION 1
Management of Patients with CHF After Hospitalization - Follow Up Serial Infusions of Natrecor
OBJECTIVE: Assess the safety and tolerability of different doses of Natrecor when administered weekly for 12 weeks. Patients selected for this study had worsening heart failure with a high risk for hospitalization.
Natrecor is indicated for the intravenous treatment of patients with acutely decompensated congestive heart failure, who have dyspnea at rest or with minimal activity. Natrecor is a vasodilator. It is the recombinant form of the endogenous human peptide called human B-type natriuretic peptide (hBNP). This is secreted by the heart as part of the body's normal response to heart failure.
PRIMARY INVESTIGATOR: Merle R. Bolton, MD
SPONSOR: Scios
TEDISAMIL
An International Study to Evaluate the Efficacy and Safety of the IV drug Tedisamil
OBJECTIVE: Demonstrate superiority of Tedisamil in converting atrial fibrillation or flutter to normal sinus rhythm after cardiac surgery.
Tedisamil is a potassium channel blocker with specific properties to slow heart rate.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: Solvay Pharmaceuticals
EPOCH
Erythropoietin Congestive Heart Failure Trial
OBJECTIVE: To evaluate the efficacy and safety of Epoetin Alfa (stimulates production of red blood cells) treatment in heart failure patients with anemia.
PRIMARY INVESTIGATOR: Puneet K. Khanna, MD
SPONSOR: Ortho-Biotech
OPUS-TIMI 16
An International Study Evaluating Orbofiban
OBJECTIVE: To evaluate the efficacy and safety of Orbofiban (antiplatelet agent) in patients with unstable coronary syndromes.
PRIMARY INVESTIGATOR: Khoi M. Le, MD
SPONSOR: G.D. Searle Co.
PREVIOUS STUDIES COMPLETED
RVA vs. RVOT
Right Ventricular Apical vs. Right Ventricular Outflow Tract Pacing Post-AV Node Ablation
OBJECTIVE: Invasive electro-physiologic and pacing techniques to improve cardiac function and quality of life.
PRIMARY INVESTIGATOR: Andrew M. Rubin, MD
CO-INVESTIGATOR: Leon A. Feldman, MD
SPONSOR: Medtronic
ADVANCE MI
Value of Angioplasty in Acute Myocardial Infarction After Treatment with Eptifibatide (antiplatelet agent) and Tenecteplase ( breaks up clots) OR Eptifibatide alone
OBJECTIVE: To evaluate the safety and efficacy of the combination treatment compared to the use of the single medication in patients with an acute MI who will have an angioplasty performed within 4 hours of administering the medication(s).
Also compare the safety of Enoxaparin, a low-molecular weight heparin, to unfractionated heparin.
PRIMARY INVESTIGATOR: Khoi M. Le, MD
SPONSOR: Millennium Parmaceuticals
PRESTO
Prevention of RE-Stenoisis with Tranilast and its's Outcomes
OBJECTIVE: To evaluate the efficiency of Tranilast (vascular injury response modifier) to prevent re-stenosis and post-angioplasty events.
PRIMARY INVESTIGATOR: Barry T. Hackshaw, MD
CO-INVESTIGATORS: Khoi M. Le, MD
Puneet K. Khanna, MD
SPONSOR: SmithKline Beecham
PRINCE
Pravastatin Inflammation/CRP Evaluation
OBJECTIVE: Determine the effect of Pravastatin (lipid lowering agent) on hs-CRP levels (high sensitivity C-reactive protein, a marker of inflammation that circulates in the blood and can help measure cardiovascular risk). Determine if the effect of Pravastatin on inflammation is similar in subjects with and without cardiovascular disease.
PRIMARY INVESTIGATOR: Charlie W. Shaeffer, MD
SPONSOR: Bristol-Myers Squibb Co.
GEMINI
Combination of Amlodipine (calcium channel blocker) and Atorvastatin (lipid-lowering agent) to treat patients with Hypertension and High Cholesterol
OBJECTIVE: To evaluate the utility of combining a medication for the treatment of hypertension with a medication for the treatment of dyslipidemia in a single pill, for patients who present with both high blood pressure and elevated lipids.
PRIMARY INVESTIGATOR: Merle A. Bolton, MD
SPONSOR: Pfizer
CONVINCE
Controlled Onset Verapamil Investigation of Cardiovascular Endpoints
OBJECTIVE: Long term prospective trial to determine whether a treatment starting with verapamil is at least as effective as a treatment starting with the standard medications (diuretic or beta blocker) in reducing the occurrence of fatal cardiovascular disease, non-fatal stroke or non-fatal
Myocardial infarction in patients with primary hypertension followed over a four to six year period.
