class com.aha.ucm.component.cis.TagListPageData=[,docNativeURL=null,docName=UCM_442723,docStatus=RELEASED,dOutDate=null,docSSFileName=UCM_442723_Late-Breaking-Clinical-Trials.jsp,docTitle=Late-Breaking Clinical Trials,xWebsites=professional,dDocAuthor=alice.wolke,xNextReviewDate=08/06/2016 8:01 PM,xTier1=33,xFeaturedItem=Yes,xElectronicRegistration=No,UserLocale=null,xSubCategory=,dpEvent=null,xComments=Programming: Scientific Sessions 2016 information on Late-Breaking Clinical Trials and Clinical Science: Special Reports,NoHttpHeaders=null,UserTimeZone=null,xRegionDefinition=GENERIC_RD_HYBRID_01,xVideoRenditions=,xSnippetItem=,xNotes=autoconverted | Late-Breaking Clinical Trials,UserDateFormat=null,encodeDocUrl=null,isDocProfileDone=null,xKeywords=Programming, Late-Breaking, Clinical, Trials, late, breaking, scientific, sessions, ss16,xTier2=116,refreshSubMonikers=null,xEditorStepReassignedUsers=null,xLinkTextToDisplay=,dDocAccount=WCM/SOP/SCON,xEndDateTime=null,xClbraAliasList=null,ClientEncoding=null,xCpdIsLocked=0,xUsageRightsDate=null,xModifyDate=10/06/2016 4:06 PM,xTier3=332,xEventDate=null,dSubscriptionType=null,xCopyright=Yes,xPackagedConversions=,dSubscriptionAlias=null,xStorageRule=,dpName=null,xDepartment=Science Operations,dStatus=RELEASED,dPublishType=,xCopyrightDetails=(C) 2016 American Heart Association. All rights reserved.,xSubType=63,isDocProfileUsed=null,xWebsiteObjectType=Data File,xWebFlag=,xSeeAlsoLinks=,xClbraUserList=null,xPartitionId=,xCpdIsTemplateEnabled=0,xLinkWebAddress=,xDontShowInListsForWebsites=,xStartDateTime=null,dInDate=10/06/2016 3:58 PM,xWebsiteSection=professional:1392,dDocName=UCM_442723,dpAction=null,dRevLabel=48,dSecurityGroup=AHAMAH-Public,xCategory=,refreshMonikers=null,xDamConversionType=,dDocFormats=null,xAssociatedImage=,dDocType=Hybrid01,xBusinessOwner=Business Owner,xUploadDate=null,xDiscussionCount=0,xMainFlowEntryCriteria=True,xItemInformation=,xUsageRights=,xDiscussionType=N/A,xRecipeTaxonomy=,dSubscriptionID=null,dOriginalName=UCM_442723.xml,xProfileTrigger=Hybrid01,dLocation=,dRevisionID=44,dPublishState=,dReleaseState=Y,xTrashDeleter=null,dMessage=,dWebExtension=xml,dExtension=xml,dProcessingState=Y,xTrashDeleteName=null,dIsCheckedOut=0,xForceFolderSecurity=null,dRevClassID=442723,dIsPrimary=1,dFileSize=37216,dIndexerState=,dFlag1=,xviaAddNewContentService=,dIsWebFormat=0,xCollectionID=null,dRevRank=0,xReadOnly=null,dCheckoutUser=,dFormat=Application/xml,dWorkflowState=,dDocID=1683766,dRendition2=,dRendition1=,xInhibitUpdate=null,dReleaseDate=10/06/2016 4:06 PM,xTrashDeleteLoc=null,dCreateDate=10/06/2016 4:06 PM,xHidden=null,labelTier1=EducationMeetings,labelTier2=MeetingsLiveCME,labelTier3=ScientificSessions,labelTier4=,mobileNavURL=DEFAULT2_VALUE_FROM_getDataForAdvanceSearch,xContactPhoneNumber=,xContactEmailAddress=,xContactName=,xATGRolesDisciplines=,xPublishDate=null,xRobotParameter=,xCommunities=,xMembershipLevel=,rsCalories=null,rsSodium=null,rsRecipeTaxonomy=null,rsServings=null,rsTotalTime=null,rsTotalFat=null,rsTotalCarbs=null,rsFeaturedImage=null,xDisplayComments=
Click the LBCT and CSSR titles below to see presenters, moderators, and schedules in the program planner.
Sunday, Nov. 13, 3:45 p.m. - 5:00 p.m.
- EUCLID – Effects of Ticagrelor Compared with Clopidogrel in Patients with Peripheral Artery Disease
The EUCLID trial was designed to test if long-term monotherapy treatment with ticagrelor would be superior to clopidogrel at preventing cardiovascular death, myocardial infarction, or ischemic stroke in patients with symptomatic PAD.
- PRECISION – Cardiovascular Outcomes with Celecoxib vs. Ibuprofen or Naproxen: The Precision Trial
This is a very large trial comparing cardiovascular outcomes with three commonly used NSAIDs in high cardiovascular risk patients
- HOPE-3 – The Effect of Blood Pressure and Cholesterol Lowering on Cognition
HOPE-3 evaluated whether long term cholesterol lowering or blood pressure lowering delayed cognitive decline
- TRUE AHF – Short- and Long-Term Effect of Immediate Vasodilator Therapy in Acutely Decompensated Heart Failure: Results of the TRUE-AHF Trial
This trial is the first to evaluate the short-and long-term benefits and risks of immediate intervention with an intravenous vasodilator drug in patients with acutely decompensated heart failure, including its long-term effects on mortality
Monday, Nov. 14, 10:45 a.m. - 12:00 p.m.
- ART – Randomized Comparison of Single Versus Bilateral Internal Mammary Artery Grafting in 2102 Patients: Effects on Major Cardiovascular Outcomes After Five Years Follow Up
These are 5 year results of the largest randomized trial of bilateral mammary artery coronary artery bypass grafting compared to standard singla mammary artery grafting plus vein grafts
- FUTURE – The FUnctional Testing Underlying Coronary Revascularization (FUTURE) Study: A “Real World” Comparison of Fractional Flow Reserve-Guided Management Versus Conventional Management in Multi Vessel Coronary Artery Disease Patients
The FUTURE study compares in a multicenter, controlled, randomized fashion FFR-guided therapeutic management to conventional therapeutic management in patients with multivessel coronary artery disease
- PIONEER AF-PCI – An OPen-label, Randomized, Controlled, Multicenter Study Exploring TwO TreatmeNt StratEgiEs of Rivaroxaban and a Dose- Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
PIONEER AF-PCI is an open-label, randomized, controlled, multicenter trial That explores two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist strategy in subjects with atrial fibrillation who undergo PCI
- GERMANY – Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve replacement for severe symptomatic aortic valve stenosis One Year results from the German Aortic Valve Registry
This analysis compares the efficacy and outcomes of intermediate-risk patients receiving TAVI or conventional SAVR from the prospective, multicenter German Aortic Valve Registry (GARY)
Tuesday, Nov. 15, 10:45 a.m. - 12:00 p.m.
- ORION 1 – Inhibition of PCSK9 Synthesis Via RNA Interference: 90 Day Data From Orion-1-a Multi-centre Phase-2 Randomized Controlled Trial
ORION 1 will provide information on safety and efficacy of using RNA interference quarterly or biannually to target intracellular PCSK9 production as a means to lower LDL-C in a large patient cohort
- GLAGOV – Effect of Evolocumab on Progression of Coronary Atherosclerosis in Statin-Treated Patients: A Placebo-Controlled Intravascular Ultrasound Trial
This trial is the first to assess the effects of a PCSK9 inhibitor on the regression or progression of coronary atherosclerosis as assessed by intravascular ultrasound
- AEGIS-1 – The Safety and Tolerability of CSL112, a Reconstituted, Infusible, Human ApoA-I, After Acute Myocardial Infarction - The ApoA-I Event Reduction in Ischemic Syndromes I (AEGIS-I) Trial
The Apo-I Event Reduction in Ischemic Syndromes I (AEGIS-I) trial is a phase 2b, multi-center, randomized, placebo-controlled, dose-ranging clinical trial that evaluated the safety and tolerability of multiple administrations of two dose arms of CSL1
- Ionis-angptl3-lRx, An Antisense Inhibitor To Angiopoietin-like Protein 3 [angptl3] Reduces Plasma Angptl3 And Lipids In Healthy Volunteers With Elevated Triglycerides
Antisense oligo against ANGPTL3 is evaluated for its effect on lipid homeostasis
- MILANO-PILOT – Impact of Infusion of an ApoA-I HDL Mimetic on Regression of Coronary Atherosclerosis in Acute Coronary Syndrome Patients: The MILANO-PILOT Study
This trial was designed to evaluate whether infusions of a HDL mimetic containing apia-I Milano would promote regression of coronary atherosclerosis
Wednesday, Nov. 16, 10:45 a.m. - 12:00 p.m.
- REDUCE LAP HF – Transcatheter Interatrial Shunt Device Provides Sustained Clinical Benefit at One Year in Patients with Preserved or Mildly Reduced Ejection Fraction: The REDUCE LAP Heart Failure Trial
This trial is designed to assess the impact of the IASD in patients with HFPEF
- ATHENA HF – Aldosterone Targeted NeuroHormonal CombinEd with Natriuresis TherApy in Heart Failure (ATHENA-HF) Trial
This trial assess the use of high dose spironolactone vs. standard of care in patients with acute heart failure
- IRONOUT HF – Oral Iron Repletion effects ON Oxygen Up Take in Heart Failure (IRONOUT HF)
Study of oral iron supplementation in patients with heart failure to determine if it improves functional capacity
- EFFECT HF – Effect of Ferric Carboxymaltose on Exercise Capacity in Patients with Iron Deficiency and Chronic Heart Failure (EFFECT-HF): A Randomized, Controlled Study
Multicentre, prospective, randomized, 2-arm study to assess the impact of ferric carboxymaltose on exercise capacity in chronic heart failure patients with iron deficiency
- MOMENTUM 3 – Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) - Primary Results of the Short Term (6 month) Cohort
This trial with innovative trial design compares HeartMate 3 to HeartMate II at 6 months for stroke-free (MRS >3) survival without pump replacement.
- MultiSENSE – A Multi-sensor Algorithm Predicts Heart Failure Events in Patients with Implanted Devices: Results from the MultiSENSE Study
This trial was designed to evaluate multiple sensors within a cardiac resychronization therapy device in order to develop an improved algorithm for monitoring HF patient status and detection of impending heart failure decompensation events.
The following sessions are Clinical Science: Special Reports. Click on the titles for more information on presenters, moderators and schedules.
Monday, Nov. 14, 3:45 p.m. - 5:00 p.m.
- MOBILE – Administration of Autologous Bone Marrow Cells for Limb Salvage in Patients with Critical Limb Ischemia: Results of the Multicenter Phase III MOBILE Trial
The MOBILE trial is the largest randomized, controlled, Phase III clinical trial to date in the U.S. to assess the efficacy of autologous cell therapy to prevent major amputation in poor option CLI patients.
- PACE - Administration of ALDH Bright Cells to Patients With Intermittent Claudication: The NHLBI CCTRN PACE Trial
This trial was designed to assess the safety and efficacy of autologous bone marrow-derived ALDH bright cells in patients with intermittent claudication
- POSEIDON-DCM – Randomized Comparison of Allogeneic vs Autologous Mesenchymal Stem Cells in Patients With Non-Ischemic Dilated Cardiomyopathy - The POSEIDON-DCM Trial
This trial was designed to test the safety and efficacy of allogeneic vs. autologous mesenchymal stem cells in patients with non-ischemic dilated cardiomyopathy.
- TIME – The NHLBI TIME Trial: Role of Microvascular Obstruction in 2-Year Clinical and MRI Follow-up
This trial presents the long-term (2-year) follow-up of patients enrolled in the NHLBI TIME trial that examined the role of timing of stem cell delivery following STEMI
Tuesday, Nov. 15, 3:45 p.m. - 5:00 p.m.
- GUASS-3 – A Genome-wide Association Study (GWAS) Identifies Novel Loci Associated With Clinically Defined Statin-Associated Muscle Symptoms in a Double-Blind Cross-Over Re-challenge Trial
This trial was designed to identify genes associated with statin-associated muscle symptoms.
- Incidence of Acute Myocardial Infarction in Patients With Genotyped Familial Hypercholesterolemia in Norway During 2001-2009
This trial was designed to report the standard incidens ratio of myocardial infarction in FH
- A Loss-of-Function Variant in CETP Is Associated With Altered Lipid Metabolism but Not With Cardiovascular Disease Incidence in Chinese Adults
This large cohort study evaluates the effects of a loss-of-function variant in the CETP gene, mimicking pharmacological inhibition of CETP, on CVD risk in Chinese adults.
- Prospective Clinical Implementation of CYP2C19-Genotype Guided Antiplatelet Therapy After PCI: a Multi-Site Investigation of MACE Outcomes in a Real-World Setting
This multi-site study was designed to determine the effect of clinical implementation of genotype-guided antiplatelet therapy on major adverse cardiovascular events after PCI.
Monday, Nov. 14, 9:00 a.m. - 10:15 a.m.
- RESPONSE 2 – A Comprehensive Lifestyle Intervention In Patients With Coronary Artery Disease: Main Results Of The Randomized Multicenter Response 2 Trial
The RESPONSE 2 trial evaluated the effect of referral of patients with CAD to comprehensive lifestyle programs, using three established, community-based interventions, on top of usual care.
- HCPIA (Argentina) – A Cluster Randomized Trial of a Comprehensive Approach for Hypertension Control in Low-income Patients in Argentina
A multilevel comprehensive intervention program improves blood pressure control among low-income hypertensive patients.
- GHP-CHANGE (FUSTER TRIAL) – A Randomized Trial of Community Health Action To Encourage healthy Behaviors: The Grenada Heart Project - CHANGE Trial
This trial was designed to test a community based peer support strategy to influence cardiovascular risk in low resource settings.
- BiomarCaRE – Large Scale Analysis of Lifetime Risk of Cardiovascular Disease in Europe and Population Attributable Risk of Cardiovascular Risk Factors. For the Biomarkers for Cardiovascular Risk Assessment in Europe (BiomarCaRE) Investigators
This study was designed to test the single and aggregate effect of cardiovascular risk factors on CVD outcome in Europe and identified the population attributable risk of traditional and novel cardiovascular risk factors on a European level.
Tuesday, Nov. 15, 10:45 a.m. – 12:00 p.m.
- SMAC-AF – Atrial Substrate Modification With Aggressive Blood Pressure Control to Prevent Atrial Fibrillation (SMAC AF)
- The San Francisco POstmortem Systematic InvesTigation of Sudden Cardiac Death (POST SCD) Study
This is a unique collaboration between cardiac electrophysiology and the county Medical Examiner to precisely determine the burden and underlying causes of every incident OOH sudden cardiac death in San Francisco via comprehensive autopsy
- RE-VERSE-AD – Idarucizumab For Dabigatran Reversal: Updated Results Of The Re-verse Ad Study
The authors will present updated results from the groundbreaking RE-VERSE AD study, which evaluates the safety and efficacy of idarucizumab as a specific reversal agent for dabigatran.
- ASSERT II – Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor in Patients with Cardiovascular Risk Factors: ASSERT II
This trial was designed to determine the prevalence of sub-clinical AF in an elderly population with common cardiovascular risk factors, such as hypertension and diabetes, using continuous ECG monitoring with an implantable cardiac monitor.