The CFST designs and performs local clinical trials of diagnostic modalities, drugs and devices. The SETCRC supports the design and performance of clinical trials to improve the diagnosis and treatment of cardiovascular disorders. The CFST is currently funding the design and development of two medical research and software projects. Additionally, the Foundation supports scholarships in healthcare and provides support to indigent patients of Southeast Texas.
3/28/1998 – 2001
Principal Investigator: Proctor & Gamble
Protocol # 1997017
ALIVE Trial
“A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL DESIGN STUDY TO DETERMINE THE EFFECT OF 75OR 100MG ORALLY ADMINISTERED AZIMILIDE DIHYDROCHLORIDE VERSUS PLACEBO ON SURVIVAL IN RECENT POST-MYOCARDIAL INFARCTION PATIENTS AT RISK OF SUDDEN DEATH.”
1/2000 – 2001
Principal Investigator:Bristol-Myers Squibb
Protocol # CV123-228
PRINCE Study
PRINCE The pravastatin inflammation CRP evaluation is an investigator-initiated, multicenter, community-based trial that will evaluate the effects of pravastatin on hs-CRP in up to 1182 individuals with coronary artery disease and up to 1702 individuals without coronary artery disease. Lipid profiles and hs-CRP levels will be obtained at baseline, 12 weeks, and 24 weeks in all study participants. Patients with known coronary artery disease will receive 40 mg/d pravastatin, whereas those without coronary artery disease will be randomly assigned to receive placebo or 40 mg/d pravastatin
9/2000 – 2001
Principal Investigator: Bristol-Myers Squibb
Protocol # CV137-120
OCTAVE Study
OCTAVE (Omapatrilat Cardiovascular Treatment Assessment Versus Enalapril) was primarily designed to see if starting with a smaller dose of omapatrilat would result in a lower incidence of angioedema. The study design involved recruiting 25,000 patients with previously treated or untreated hypertension who were randomized to be treated with either enalapril (starting at 5 mg and increasing to 40 mg daily) or omapatrilat (10-80 mg). Patients with a history of angioedema, anaphylaxis, or multiple drug allergies were excluded. For the first 8 weeks only the study drugs could be used, but at 8 and 16 weeks additional medications could be added to try to get the patients to the goal blood pressure of 140/90 mm Hg. Throughout the 24-week study the blood pressure readings were lower (by about 3/2 mm Hg) in the omapatrilat group. The primary hypothesis was that by starting with the smaller dose of omapatrilat the incidence of angioedema would be no greater than twice the amount seen with enalapril, putting omapatrilat in the ballpark of the ACE inhibitors. However, the data failed to confirm this hypothesis, and showed a risk that was 3.2 times higher than that for enalapril. An independent committee that adjudicated the reported angioedema events concluded that there were 274 events in the omapatrilat group, and 86 in the enalapril group.
1/2000 – 12/2001
Principal Investigator: Parke-Davis Pfizer
Protocol # 981-400-421
Sage Study-how lowering lipids effects myocardial ischemia in elderly
The SAGE trial is a prospective, randomized, double-blind, parallel-arm study enrolling men and women with stable CHD at 192 centers worldwide. Qualifying participants (aged 65-85 years; low-density lipoprotein cholesterol 100-250 mg/dL) have had at least 1 episode of myocardial ischemia with total ischemia duration >or=3 minutes on 48-hour ambulatory electrocardiographic (AECG) monitoring performed during routine daily activities. Participants have been randomized to either atorvastatin 80 mg/day (aggressive lipid lowering) or pravastatin 40 mg/day (moderate lipid lowering). The primary efficacy measure is the absolute change in the total duration of myocardial ischemic events on 48-hour AECG monitoring from baseline to month 12.
2/2000 – 4/2002
Principal Investigator: G.E. Searls and Co.
Protocol # IE3-99-02-035
Ephesus Study – Post MI study
Eplerenone versus placebo in patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure.
2000 – 12/2001
Principal Investigator: NitroMed
Protocol # NDA # 20-727
A-HeFT Study – African American Heart Failure Trial
A-HeFT: African-American Heart Failure Trial — Effect of Combination Isosorbide Dinitrate/Hydralazine on Left Ventricular Structure and Function
5/1/2002
Principal Investigator: Pfizer
Protocol # A3841012
Gemini Study – Lipitor/ Norvasc
GEMINI study was a 14-week, open-label, noncomparative, multicenter trial designed to evaluate the efficacy and safety of the atorvastatin/amlodipine fixed dose combination pill as initial or add-on (integrated) therapy in the treatment of concomitant hypertension and dyslipidemia.
8/2002 – 2005
Principal Investigator: Aventis
Protocol XRP4563B/4001
Rescue ACS Study – Acute Coronary Syndrome Study – Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome
12/2003 – 12/2006
Principal Investigator: Otsuka Maryland Research Institute
Protocol 156-03-236
Acute Decompensated – CHF Study
EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan
The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).
9/2006 – 9/2007
Principal Investigator: Pfizer
Protocol A3841046
HTN and Hyperlipidemia– Caduet
CUSP -HTN and HyperlipidemiaAn 8-Week Randomized, Double-Blind, Placebo-Controlled Trial Examining The Efficacy And Safety Of Caduet® In Simultaneously Achieving Blood Pressure And Lipid Goals In An Untreated Hypertensive And Dyslipidemic Subject Population. (CUSP – Caduet in Untreated Subject Population)
7/2004 – 12/2006
Principal Investigator: Pfizer
Protocol A5091043
Hypercholesterolemia and CV events– torceptrapib/atorvastatin
ILLUMINATE – A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease (ILLUMINATE) -The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, Phase 3 Multi Center, Double Blind, Randomized, Parallel Group Evaluation Of The Fixed Combination Torcetrapib/Atorvastatin, Administered Orally, Once Daily (Qd), Compared With Atorvastatin Alone, On The Occurrence Of Major Cardiovascular Events In Subjects With Coronary Heart Disease Or Risk Equivalents when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents
12/2005 – 9/2007
Principal Investigator: AstraZeneca
Protocol 4522US/0001
ACS– Rosuvastatin/Atorvastatin
LUNAR -The LUNAR study is a prospective, multicenter, randomized, open-label, 3-arm, parallel-group, 12-week study begun in September 2003 (AstraZeneca study D3560L00021 [4522US/0001]). The primary objective of the LUNAR study is to compare the efficacy of rosuvastatin 20 and 40 mg with that of atorvastatin 80 mg in lowering levels of LDL-C over 6 to 12 weeks of once-daily therapy. Study investigators are blinded to the results of end-point assessments.
8/2006 – 4/2009
Principal Investigator: Amgen, Inc
Protocol 20050222
Heart Failure and Anemia– Darbepoetin Alfa
RED HF-A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia
10/2005 – 2007
Principal Investigator: Lilly
Protocol H7T-MC-TAAL
ACS– Prasugrel and ASA vs. Clopidogrel and ASA
TIMI 38 – Protocol H7T-MC-TAAL -A subset of the TRITON–TIMI 38 study (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel–Thrombolysis In Myocardial Infarction 38), in which patients with acute coronary syndrome were randomized to treatment with aspirin and either clopidogrel or prasugrel, underwent isolated CABG (N = 346). A supplemental case report form was designed and administered, and the data combined with the existing TRITON–TIMI 38
2/2006 – 6/2009
Principal Investigator: Amgen, Inc.
Protocol 20010184
Diabetes, CKD, and anemia– Darbepoetin Alfa
TREAT -Trial to Reduce Cardiovascular Events With Aranesp® Therapy
The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus.
6/2006 – 12/2006
Principal Investigator: Palatin Technologies
Protocol PT-141-2006-32
HTN safety for ED drug– PT-141
8/2006 – 6/2008
Principal Investigator: Novartis
Protocol CVAL489AUS62
Observational Study for BP– Diovan and Lotrel
BLISS – Blood Pressure Success Zone-BLISS was designed to evaluate the effect of the BPSZ Program on key outcome measures such as the proportion of patients achieving BP control, medication persistence, treatment adherence and satisfaction. This observational, multicentre study was approved by a central ethics review board. The Blood Pressure Success Zone (BPSZ) Program is a comprehensive, patient-centred, treatment, education and support programme designed to improve persistence and adherence with antihypertensive medication.
2006 – 2010
Principal Investigator: Johnson & Johnson
Protocol 9039039 AFL301
Atrial Fibrillation– Rivaroxiban and Coumadin
ROCKET – A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
12/2006 – 2012
Principal Investigator: Pfizer
Protocol A3191172
Osteoarthritis and Rheumatoid Arthritis– Celebrex, Naproxen and Aleve
PRECISION – A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen
2006 – 5/2009
Sub-Investigator: Reliant
Protocol OM8
Atrial Fibrillation– Omacor
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of Lovaza for the Prevention of Recurrent, Symptomatic Atrial Fibrillation
2006 – 6/2009
Sub-Investigator: Gilead
Protocol DAR312
Resistant Hypertension– Darusentan and Guanfacine
DORADO-AC (DAR-312) is an international Phase III double-blind, placebo- and active-controlled, parallel group trial, in which approximately 770 patients will be randomized to receive darusentan (titrated to the optimal dose of 50, 100 or 300 mg once daily), an active comparator (guanfacine 1 mg once daily) or placebo. The co-primary endpoints of the trial are the changes from baseline to week 14 in trough sitting SBP and trough sitting DBP, as measured by sphygmomanometry.
3/2007 – 12/2008
Principal Investigator: Merck
Protocol 112-01
Hypercholesterolemia– Exetimibe and Atorvastatin
A Multicenter, Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Elderly Patients With Hypercholesterolemia at High Risk for CHD
5/2008 – 01/2009
Principal Investigator: Cogentus
Protocol CG104
Reduce GI Events and Bleeding– Clopidogrel and CGT-2168
A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease
11/2008 – 6/2009
Principal Investigator: Bristol Myers Squibb/Pfizer
Protocol CV 185057
Deep Vein Thrombosis and Pulmonary Embolism– Apixiban
AMPLIFY EXT -A randomized, parallel-group, double-blind, placebo-controlled study in subjects with symptomatic proximal DVT or symptomatic PE.
02/2009 – 2009
Principal Investigator: Roche
Protocol NC20971C
Hypercholesterolemia-dalcetrapib
A randomized, double-blind, placebo-controlled study assessing the effect of RO4607381 on cardiovascular mortality and morbidity in clinically stable patients with a recent acute coronary syndrome
04/2010 – 8/2014
Principal Investigator: Novartis
Protocol CLCZ696B2314
Chronic heart failure and reduced LVEF. – enalapril – ACE /NEP Inhibitor
PARADIGM-HF is a randomized, double-blind, Phase III outcome study evaluating the efficacy and safety profile of LCZ696 versus enalapril (a widely used ACE inhibitor) in 8,436 patients with heart failure with reduced ejection fraction
03/2010 – 1/2012
Principal Investigator: Pozen
Protocol PA32540-302
Incidence of Gastric Ulcers – ASA /omeprazole
A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
07/2010 – 8/2014
Principal Investigator: Ortho-McNeil Janssen
RIVAROX-AFL-4001
ORBIT – Atrial Fibrillation Observational Registry
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation
04/2011 – 1/2012
Sub-Investigator: Novartis
Protocol CSPV100AUS02
VIVID – Hypertension / Type 2 Diabetes– Aliskiren / Valsartan
A Phase IV, 8 Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Antihypertensive Efficacy and Safety of Aliskiren Administered in Combination With Valsartan Versus Valsartan Alone in Patients With Stage 2 Systolic Hypertension and Type 2 Diabetes Mellitus
04/2011 – Present
Principal Investigator: Novartis
Protocol CACZ885M2301
CANTOS – Post Myocardial Infarction / elevated hsCRP– canakinumab
CANTOS – Randomized, Double-blind, Placebo-controlled, Event Driven Trial of Quarterly Subcutaneous Canakinumab in the Prevention of Recurrent Cardiovascular Events Among Stable Post-Myocardial Infarction Patients With Elevated hsCRP Including Substudies to Evaluate the Effect of Canakinumab on Carotid Atherosclerosis, and on Glucose Control Following OGTT in T2DM
11/2011 – Present
Sub Investigator: Boston Scientific
Multi-SENSE Device Trial
Cognis – CRT -Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients
05/2012 – Present
Principal Investigator: Amarin
Protocol AMR -01-01-0019
Reduce-It Trial
REDUCE-IT -Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA – Intervention Trial)
08/2012 – Present
Principal Investigator: Boehringer Ingleheim
GLORIA-AF
New Onset Atrial Fibrillation Registry
GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation
08/2012 – 12/2013
Principal Investigator: Astra Zeneca
Protocol D513L00013
Ethnicity Study-Stable CAD
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in African American Patients With Stable Coronary Artery Disease
08/2012 – 4/2013
Principal Investigator: Takeda
Protocol SYR-322-402
EXAMINE- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
08/2012 – 2/2015
Sub-Investigator: DCRI / NIH
Protocol 1U01HL086755.01A1
BRIDGE -Bridging Anticoagulation in Patients who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery
08/2013 – Present
Sub-Investigator: Boston Scientific
LSS of 4-SITE –Longitudinal Surveillance Study of the 4-SITE Lead/Header System
11/2013 – 2014
Principal Investigator: Novartis
Protocol CLCZ696B2228
TITRATION Trial– enalapril – ACE /NEP Inhibitor – A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy
2/2014 – Present
Principal Investigator: NHLBI
CIRT Trial – Methotrexate – A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Weekly Low-dose Methotrexate (LDM) in the Prevention of Cardiovascular Events Among Stable Coronary Artery Disease Patients With Type 2 Diabetes or Metabolic Syndrome
4/2014 – Present
Sub-Investigator: Boston Scientific
NAVIGATE X4 – Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads: NAVIGATE X4
4/2014 – 8/2015
Sub-Investigator: ARCA Biopharma
GENETIC-AF – A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients With Heart Failure
6/2014 – 3/2015
Principal Investigator: Sanofi
Multaq Chart Review – Atrial Fibrillation – Real-world Study Evaluating Dronedarone Treatment Patterns and Outcomes in Patients with Atrial Fibrillation: Wave 2
7/2014 – Present
Principal Investigator: Novartis
Protocol CLCZ696D2301
PARAGON– enalapril – ACE /NEP Inhibitor-A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction
8/2014 – Present
Sub-Investigator: Pfizer / BMS
Protocol B0661025 / CB185-267
EMANATE -Phase IV clinical trial (Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF) assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) undergoing cardioversion.
06/2013 – Present
Principal Investigator: Ortho-McNeil Janssen
RIVAROX-AFL-4002
ORBIT II – Atrial Fibrillation Observational Registry – SATELLITE – Substudy 2015- The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a multicenter, prospective outpatient disease registry to evaluate the utilization of target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin inhibitors, and associated outcomes. Importantly, the ORBIT AF II registry will permit the collection and analysis of post-approval observational data needed for evaluating the outcomes associated with these new agents when used in broader patient populations outside of clinical studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial fibrillation (AF) as well as those who have been recently started on a target-specific oral anticoagulant agent. Taken together, the ORBIT-AF I and ORBIT-AF II registries will offer a broad and contemporary view of AF therapy.
06/2015 – Present
Principal Investigator: AstraZeneca
D513BC00001
THEMIS – A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus
08/2015 – Present
Principal Investigator: Regeneron / DCRI
PALM REGISTRY -Patient and Provider Assessment of Lipid Management Registry
08/2015 – Present
Principal Investigator: Pfizer
B1481022
SPIRE 1 – Studies of PCSK9 Inhibition and the Reduction of vascular Events – SPIRE 1PHASE 3 MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED,PLACEBO-CONTROLLED, PARALLEL GROUP EVALUATION OF THE
EFFICACY, SAFETY, AND TOLERABILITY OF BOCOCIZUMAB (PF-04950615),IN REDUCING THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTSIN HIGH RISK SUBJECTS
08/2015 – Present
Principal Investigator: Pfizer
B1481038
SPIRE 2 –is evaluating the efficacy and safety of bococizumab compared to placebo in reducing the risk of major cardiovascular events among approximately 10,600 patients at high risk for cardiovascular disease – including those without a prior history of cardiovascular events – who are on highly-effective statins or with documented statin intolerance.
01/2016 – Present
Principal Investigator: Novartis
CLCZ696BUS02
CHAMP-HF- Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection Fraction
4/2014 – Present
Sub-Investigator: Boston Scientific
Expanding MRI Access for Patients With New and Existing ICDs and CRT-Ds ( ENABLE MRI) (ENABLE MRI) The objective of this study is to collect data to confirm the safety and effectiveness of the ImageReady™ MR Conditional Defibrillation System when used in the 1.5T MRI environment under the labeled Conditions of Use
