Late-Breaking Clinical Trials
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LBCT.01 Practice Implications for CAD and VTE Sun., Nov. 4, 2012 / 3:30pm-5:20pm
Aspirin for The Prevention of Recurrent Venous Thromboembolism After a First Unprovoked Event: Results of the ASPIRE Randomized Controlled Trial
ASPIRE: This trial is investigating the efficacy of aspirin in preventing recurrent venous thromboembolism (VTE) in patients with first unprovoked VTE
A Randomized Trial of Bedside Platelet Function Monitoring to Adjust Antiplatelet Therapy Versus Standard of Care in Patients Undergoing Drug Eluting Stent Implantation: The ARCTIC Study
ARCTIC was designed to compare a strategy of monitoring platelet function at the bedside to adjust antiplatelet therapy to standard of care in patients having drug eluting stent implantation.
First Large-Scale Platelet Function Evaluation in an Acute Coronary Syndromes Trial - The TRILOGY ACS Platelet Function Sub-study
TRILOGY ACS is an international, phase 3, randomized trial comparing the platelet inhibitor prasugrel+aspirin with clopidogrel+aspirin in medically managed US/NSTEMI ACS patients.
Results of the Trial to Assess Chelation Therapy
The Trial to Assess Chelation Therapy (TACT) is an NIH-sponsored randomized, double blind clinical trial testing the benefits and risks of 40 infusions of a standard ethylene diamine tetra-acetic (EDTA)-chelation solution compared with placebo in patients with coronary artery disease.
Main Results of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial
FREEDOM - This trial was designed to determine whether coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) is the superior approach for revascularization of diabetic patients with multivessel coronary artery disease.
Aspirin for The Prevention of Recurrent Venous Thromboembolism After a First Unprovoked Event: Results of the ASPIRE Randomized Controlled Trial
ASPIRE: This trial is investigating the efficacy of aspirin in preventing recurrent venous thromboembolism (VTE) in patients with first unprovoked VTE
A Randomized Trial of Bedside Platelet Function Monitoring to Adjust Antiplatelet Therapy Versus Standard of Care in Patients Undergoing Drug Eluting Stent Implantation: The ARCTIC Study
ARCTIC was designed to compare a strategy of monitoring platelet function at the bedside to adjust antiplatelet therapy to standard of care in patients having drug eluting stent implantation.
First Large-Scale Platelet Function Evaluation in an Acute Coronary Syndromes Trial - The TRILOGY ACS Platelet Function Sub-study
TRILOGY ACS is an international, phase 3, randomized trial comparing the platelet inhibitor prasugrel+aspirin with clopidogrel+aspirin in medically managed US/NSTEMI ACS patients.
Results of the Trial to Assess Chelation Therapy
The Trial to Assess Chelation Therapy (TACT) is an NIH-sponsored randomized, double blind clinical trial testing the benefits and risks of 40 infusions of a standard ethylene diamine tetra-acetic (EDTA)-chelation solution compared with placebo in patients with coronary artery disease.
Main Results of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial
FREEDOM - This trial was designed to determine whether coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) is the superior approach for revascularization of diabetic patients with multivessel coronary artery disease.
LBCT.02 Health Economics and Quality of Life in Contemporary Trials Sun., Nov. 4, 2012 / 5:30pm-6:43pm
Prospective Evaluation of Outcomes With Stress Perfusion Imaging Versus Stress Wall Motion Imaging During Dobutamine or Exercise Echocardiography
POISE-This prospective randomized trial compares stress perfusion imaging with stress wall motion imaging in predicting patient outcomes.
Economic Outcomes of Percutaneous Coronary Intervention Performed at Sites With and Without On-Site Cardiac Surgery
This study is designed to determine whether total medical costs at 9 months were lower for subjects undergoing percutaneous coronary intervention at a hospital without versus with on-site surgery.
Quality of Life Outcomes in the Trial to Assess Chelation Therapy (TACT)
This study examined quality of life outcomes in the Trial to Assess Chelation Therapy (TACT), an NIH-funded, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial comparing 40 infusions of a ethylene diamine tetra-acetic (EDTA)-chelation solution with placebo in patients with coronary artery disease.
Cost-Effectiveness of PCI with Drug Eluting Stents versus Bypass Surgery for Patients with Diabetes and Multi-vessel Coronary Artery Disease: Results from the FREEDOM Trial
FREEDOM - This trial was designed to compare the cost-effectiveness of coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug eluting stents for revascularization of diabetic patients with multivessel coronary artery disease.
LBCT.03 Treatments for Prevention of Cardiovascular Events: A Population Perspective Mon., Nov. 5, 2012 / 9:00am-10:28am
Omega-3 fatty Acids for the Prevention of Recurrent Symptomatic Atrial Fibrillation: Results of a double-blind randomized clinical trial (FORWARD) (NCT00597220)
To evaluate the efficacy of chronic supplementation with n-3 PUFA for the prevention of recurrent symptomatic AF in patients with previous AF who were at normal sinus rhythm at randomization.
Fish Oil for the Prevention of Post-Operative Atrial Fibrillation - The Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA) Trial
OPERA is a randomized, double-blind, placebo-controlled, clinical trial to investigate effects of omega-3 fatty acids on risk of post-op atrial fibrillation.
A Randomized Trial of a Multivitamin in the Prevention of Cardiovascular Disease in Men: The Physicians’ Health Study II
Physicians' Health Study II - This long-term trial tests whether a commonly used multivitamin can prevent cardiovascular disease in middle-aged and older men.
Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE)
UMPIRE - a randomised controlled trial assessing the impact of a combination polypill-based strategy on medication adherence and outcomes in patients with high cardiovascular risk in India and Europe.
LBCT.04 Novel Treatments for Managing Lipid Disorders Mon., Nov. 5, 2012 / 10:45am-11:55am
Reduction of LDL-C with PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD): Interim Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial
This phase 2, double-blind, placebo-controlled trial was designed to evaluate the efficacy and tolerability of PCSK9 inhibition by AMG 145 on Low-Density Lipoprotein Cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia who were on stable doses of statin.
Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects (GAUSS): Interim Results from a Randomized, Double-blind, Placebo-controlled Study
This trial was designed to assess the efficacy, safety, and tolerability of an anti-PCSK9 antibody in patients who could not tolerate effective statin doses .
Effects of 12 Weeks of Treatment with RN316 (PF-04950615), a Humanized IgG2Δa Monoclonal Antibody Binding Proprotein Convertase Subtilisin Kexin Type 9, in Hypercholesterolemic Subjects on High and Maximal Dose Statins
Two Phase 2, double-blind, randomized, placebo-controlled studies assessed efficacy, safety and tolerability of RN316 in hypercholesterolemic subjects on ongoing high to maximal doses of statins.
Effects of the Cholesteryl Ester Transfer Protein Inhibitor Dalcetrapib in Patients with Recent Acute Coronary Syndrome
This trial was designed to evaluate the effect of the cholesteryl ester transfer protein (CETP) inhibitor, dalcetrapib, on major cardiovascular outcomes in patients with recent acute coronary syndrome.
LBCT.05 Cell-Based Therapies for Myocardial Regeneration Tues., Nov. 6, 2012 / 10:45am-12:00pm
Results of the Swiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (Swiss Ami) Trial
Swiss Ami - This trial was designed to evaluate whether left ventricular function after acute myocardial infarction treated by PCI is improved by intracoronary infusion of BMCs
The ALCADIA (Autologous Human Cardiac-derived Stem Cell To Treat Ischemic Cardiomyopathy) Trial
This trial was designed to evaluate the safety and efficacy on the transplantation of autologous human cardiac-derived stem cells (hCSCs) with the controlled release of bFGF to severe refractory heart failure patients with chronic ischemic cardiomyopathy.
The Effect of Timing of Stem Cell Delivery Following Acute Myocardial Infarction: The NHLBI and CCTRN TIME Trial
Evaluated the effect of timing of stem cell therapy after Acute Myocardial Infarction.
Randomized Comparison of Allogeneic vs Autologous Mesenchymal Stem Cells in Patients with Ischemic Cardiomyopathy
POSEIDON - This trial was designed to test the safety and efficacy of allogeneic vs. autologous mesenchymal stem cells in patients with ischemic cardiomyopathy
Effect of Cardiac Stem Cells in Patients with Ischemic Cardiomyopathy: Interim Results of the SCIPIO Trial Up to 2 Years After Therapy
SCIPIO: (Cardiac) Stem Cell Infusion in Patients with Ischemic cardiOmyopathy
LBCT.06 Management of LV Dysfunction: Devices and Drugs Tues., Nov. 6, 2012 / 3:45pm-5:35pm
MADIT Randomized Trial to Reduce Inappropriate Therapy (MADIT-RIT)
The MADIT-RIT trial was designed to determine if prespecified ICD or CRT-D device programming will safely reduce inappropriate therapy compared to standard programming.
Biventricular versus Right Ventricular Pacing in Patients with Left Ventricular Dysfunction and Atrioventricular Block (BLOCK HF Study)
BLOCK HF-This trial was designed to determine if AV block patients who require pacing would benefit from biventricular pacing as compared to right ventricular pacing as evidenced by a slowing in the progression to heart failure.
Pilot Trial of Two Levels of Hypothermia in Comatose Survivors from Out-of-Hospital Cardiac Arrest
This pilot study was conducted to compare the efficacy of different hypothermia temperature targets in treating comatose survivors of out-of-hospital cardiac arrest.
The RELAXin in Acute Heart Failure (RELAX-AHF-1) Trial
The RELAX-AHF-1 trial evaluated the effect of relaxin compared to placebo for safety and efficacy in patients with acute heart failure.
Cardiorenal Rescue Study in Acute Decompensated Heart Failure: Results of CARRESS-HF, for the Heart Failure Clinical Research Network
CARRESS-HF: This trial was designed to evaluate the safety and efficacy of ultrafiltration versus stepped pharmacologic care in managing patients with acute decompensated heart failure and worsening renal function.
CS.01 Prevention and Treatment of Ischemic Heart Disease: Novel Approaches Mon., Nov. 5, 2012 / 7:30am-8:46am
Low Dose Colchicine for Secondary Prevention of Cardiovascular Disease [LoDoCo]: A Randomized Controlled Trial
The LoDoCo trial was designed to determine whether colchicine given in addition to standard medical therapy therapy is effective for the prevention of major cardiovascular endpoints in patients with stable coronary artery disease.
Results of the Responses of Myocardial Ischemia to Escitalopram Treatment Trial
This trial examines the effects of escitalopram, a selective serotonin reuptake inhibitor (SSRI) , on mental stress-induced myocardial ischemia (MSIMI) in coronary heart disease patients.
Safety and Efficacy of Losmapimod in Non-ST-Segment Elevation Acute Myocardial Infarction: Results of the SOLSTICE Phase 2 Randomized Trial
SOLSTICE (Study Of LoSmapimod Treatment on Inflammation and InfarCt SizE) is a randomized, double-blind, placebo-controlled, parallel group, multicenter phase 2a study to evaluate safety and efficacy of 12-week treatment with 2 dose regimens of losmapimod (GW856553), a potent oral p38-MAPK inhibitor, versus placebo (randomized 3:3:2) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) expected to undergo an invasive strategy.
EnligHTN™ I, First-in-man Multi-center Study of a Novel Multi-electrode Renal Denervation Catheter in Patients with Drug-Resistant Hypertension
EnligHTN I: This study was designed to study the efficacy and safety of a new radio frequency ablation catheter in patients withdrug-resistant resistant hypertension.
Low Dose Colchicine for Secondary Prevention of Cardiovascular Disease [LoDoCo]: A Randomized Controlled Trial
The LoDoCo trial was designed to determine whether colchicine given in addition to standard medical therapy therapy is effective for the prevention of major cardiovascular endpoints in patients with stable coronary artery disease.
Results of the Responses of Myocardial Ischemia to Escitalopram Treatment Trial
This trial examines the effects of escitalopram, a selective serotonin reuptake inhibitor (SSRI) , on mental stress-induced myocardial ischemia (MSIMI) in coronary heart disease patients.
Safety and Efficacy of Losmapimod in Non-ST-Segment Elevation Acute Myocardial Infarction: Results of the SOLSTICE Phase 2 Randomized Trial
SOLSTICE (Study Of LoSmapimod Treatment on Inflammation and InfarCt SizE) is a randomized, double-blind, placebo-controlled, parallel group, multicenter phase 2a study to evaluate safety and efficacy of 12-week treatment with 2 dose regimens of losmapimod (GW856553), a potent oral p38-MAPK inhibitor, versus placebo (randomized 3:3:2) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) expected to undergo an invasive strategy.
EnligHTN™ I, First-in-man Multi-center Study of a Novel Multi-electrode Renal Denervation Catheter in Patients with Drug-Resistant Hypertension
EnligHTN I: This study was designed to study the efficacy and safety of a new radio frequency ablation catheter in patients withdrug-resistant resistant hypertension.
CS.02 New Insights into Management of Common Cardiovascular Disorders Mon., Nov. 5, 2012 / 5:30pm-6:40pm
A Randomised Trial to Assess Catheter Ablation versus Rate Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure
ARC-HF. This trial was designed to evaluate ablation versus rate control in management of patients with persistent atrial fibrillation and heart failure.
Pulmonary Antrum Radial-linear Ablation of Paroxysmal Atrial Fibrillation: First-in-human Multicenter Clinical Outcome
This trial examines the efficacy and safety of pulmonary vein (PV) antrum radial-linear ablation in paroxysmal AF patients.
Prospective Randomized Study to Assess the Efficacy of Site and Rate of Atrial Pacing on Long-term Progression of Atrial Fibrillation in Sick Sinus Syndrome- Septal Pacing for Atrial Fibrillation Suppression Evaluation [SAFE] Study
SAFE-This prospective randomized study was designed to assess the efficacy of site and rate of atrial pacing on long-term progression of atrial fibrillation in sick sinus syndrome
Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT)
LEPHT was designed to assess the effects of riociguat on hemodynamics, safety, and functional outcomes in heart failure patients with left ventricular dysfunction and secondary pulmonary hypertension.
Sildenafil and Diastolic Dysfunction After Acute Myocardial Infarction in Patients with Preserved Ejection Fraction - A Prospective, Double Blinded Placebo-controlled Randomized Trial (SIDAMI)
SIDAMI - SIldenafil and Diastolic dysfunction after Acute Myocardial Infarction in patients with preserved ejection fraction – A prospective, double blinded placebo-controlled randomized trial.
CS.03 Emerging Therapeutics for Diabetes and Dyslipidemia Tues., Nov. 6, 2012 / 7:30am-8:25am
Impact of LX4211, a Dual Inhibitor of Sodium Glucose Transporter 1 and 2 on Cardiovascular Risk Factors in Type 2 Diabetes
This trial was designed to evaluate the safety and efficacy of LX4211 in combination with metformin in subjects with type 2 Diabetes mellitus who have inadequate glycemic control on metformin monotherapy.
LAPLACE-TIMI 57 Primary Results
LAPLACE-TIMI 57 was 12-week, randomized, double-blind, dose-ranging, placebo-controlled study designed to assess the efficacy, safety, and tolerability of AMG 145 (a PCSK9 inhibitor) when added to statin therapy in patients with hypercholesterolemia.
Efficacy and Safety of a Fully Human Monoclonal Antibody Against PCSK9 as Monotherapy for Hypercholesterolemia: Results from the MENDEL Study, a Global Phase 2 Trial of AMG 145
MENDEL- This randomized, double-blind, placebo- and ezetimibe-controlled trial to evaluate the Efficacy and Safety of a Fully Human Monoclonal Antibody Against PCSK9 ( AMG 145) as Monotherapy for Hypercholesterolemia.
AMG 145, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin Kexin type 9 (PCSK9), Facilitates Achievement of NCEP LDL-Cholesterol Goals in High-Risk Patients
This trial examines the impact of AMG 145, a fully human monoclonal antibody against proprotein convertase subtilisin kexin type 9 (PCSK9), on achieiving NCEP LDL-Cholesterol goals in high-risk patients.
CS.04 Valvular Heart Disease, PAD, Atrial Fibrillation: International Perspectives Wed., Nov. 7, 2012 / 10:45am - 12:15pm
Mitral Valve Annuloplasty Plus CABG versus CABG only in Moderate Functional Ischemic Mitral Regurgitation: Final Results of the Randomized Ischemic Mitral Evaluation (RIME) Trial
RIME - This trial was designed to evaluate if mitral valve annuloplasty in addition to coronary artery bypass grafting was more beneficial in moderate functional ischemic mitral regurgitation than CABG only.
EndOVascular Treatment for Infra-inguinal Vessel, in Patients With Critical Limb Sichemia (olive) Registry in Japan
This study was designed to assess the efficacy and safety of endovascular treatment for Japanese patients with critical limb ischemia due to infrainguinal lesion.
Management and One Year Outcome of Atrial Fibrillation in Middle Eastern Cohort Enrolled in the Observational Gulf Survey of Atrial Fibrillation Events (Gulf SAFE)
Observational Registry of atrial fibrillation management and outcomes in the Gulf region of the Middle East.
Clinical Implications of Device-Detected Atrial Tachyarrhythmias: Results from the Registry of Atrial Tachycardia and Atrial Fibrillation Episodes in the Cardiac Rhythm Management Device Population (RATE)
The outcome-oriented “RATE Registry” was designed to evaluate the clinical implications, if any, of pacemaker or defibrillator documented atrial fibrillation or atrial tachycardia.
Antithrombotic Treatments and Associated Outcomes in Patients with Atrial Fibrillation: The Global Anticoagulant Registry in the FIELD (GARFIELD)
This global registry gathered data about newly diagnosed AF patients to provide information about the clinincal management and outcomes in various healthcare settings and parts of the world.
Randomized Comparison of the Effects of Two Doses of Dabigatran Etexilate on Clinical Outcomes Over 4.3 Years: Results of the Rely-able Double-blind Randomized Trial
Long-term randomized follow up of patients receiving dabigatran - a comparison of effects of two doses on clinical outcomes.
