A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

Date Added
June 25th, 2021
PRO Number
Pro00111185
Researcher
Priya Kumar

List of Studies

Keywords
Coronary Artery Disease
Summary

Acute coronary syndrome is a life-threatening condition, which most commonly occurs when an atherosclerotic plaque ruptures or erodes, leading to thrombus formation within a coronary artery. A thrombus within a coronary artery can result in unstable angina, MI, or sudden death. Even after recovery from an acute episode of ACS, patients continue to be at heightened risk. The risk of recurrent CV events is high despite advances in medical therapy and standard therapeutic
regimens that have produced important improvements in the prognosis of patients with MI.
CSL112 is a novel formulation of apoA-I, the major functional component of high-density lipoprotein. It is purified from human plasma, formulated to deliver exogenous apoA-I. Apolipoprotein A-I is formulated with phosphatidylcholine (PC) and stabilized with sucrose and cholate as excipients. CSL112 is being developed for use in patients with ACS (diagnosed with either STEMI or NSTEMI) to reduce the risk of CV death, MI, and stroke upon delivery of CSL112. Evidence from the Apo-I Event Reducing in Ischemic Syndromes-I (AEGIS-I) study has demonstrated that administration of apoA-I increases cholesterol efflux in MI patients.
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events (MACE) in subjects with ACS (diagnosed with STEMI or NSTEMI), who are receiving evidence-based medical therapy.
Subjects will be randomized 1:1 to 1 of 2 treatment groups (CSL1126 g or placebo). Randomization at baseline will be stratified by subjects' index MI type (STEMI vs NSTEMI), management of the index MI (PCI vs medically managed), and region (North America, Latin America, Western Europe, Central and Eastern Europe, or Asia Pacific). The study will consist of a Screening Period, an Active
Treatment Period, and a Follow-up Period. Investigational product will be administered by intravenous (IV) infusion once weekly for 4 consecutive weeks. The primary efficacy outcome will be the composite of CV death, MI, or stroke from time of randomization through 90 days. Adverse event monitoring will continue through Visit 8 (Day 90), and all serious adverse events will be collected
through the end of the study, regardless of relationship to investigational product. Subjects will be followed for occurrence of MACE for 365 days from randomization.

Institution
Self Regional
Recruitment Contact
Heather Rich
8649432416
heather.rich@selfregional.org

COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes

Date Added
June 25th, 2021
PRO Number
Pro00111177
Researcher
Priya Kumar

List of Studies

Keywords
Coronary Artery Disease, Diabetes
Summary

COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with T2DM and CVD. The trial will be performed and interpreted in the context of clinical diabetes care in the U.S. using data from select electronic health record (EHR) sites. A subset of sites with EHR data available for querying in existing datamarts will be recruited to participate in two EHRfocused objectives: 1) to perform a baseline characterization of patients with T2DM and CVD, including demographics, treatment patterns and healthcare utilization such as hospitalization; and 2) to assist with the identification of patients eligible for the educational intervention trial.

Institution
Self Regional
Recruitment Contact
Heather Rich
864-943-2416
heather.rich@selfregional.org

Multicenter Study Into Individualized Scanning for Coronary Artery Disease (MINDS-CAD)

Date Added
July 14th, 2020
PRO Number
Pro00100282
Researcher
Uwe O.P. Schoepf

List of Studies


Keywords
Cardiovascular, Coronary Artery Disease
Summary

This study uses CT scans to visualize the heart and surrounding arteries to look for coronary artery disease. This study takes into account individuals body type including size, weight, and heart rate to tailor the CT scan and contrast media given to each patient. Taking into account each patients body will allow doctors to obtain the best image possible while reducing the amount of contrast media given to patients.

Institution
MUSC
Recruitment Contact
Hunter Gray
8438764922
grayhu@musc.edu

Management of Patients Presenting with Acute Chest Pain Following Coronary Computed Tomography Angiography

Date Added
July 9th, 2019
PRO Number
Pro00087460
Researcher
Uwe O.P. Schoepf

List of Studies


Keywords
Cardiovascular, Coronary Artery Disease
Summary

Patients who present to MUSC's Chest Pain Center with acute chest pain and have undergone coronary computerized tomography angiography or triple rule-out computed tomography imaging showing an intermediate stenosis will be prospectively selected. Consented patients will then have their clinical indicated coronary computerized tomography angiography or triple rule-out computed tomography imaging undergo an expedited computed tomography-fractional flow reserve analysis analysis. This analysis will be provided to Chest Pain Center physician of record to aid in downstream patient treatment decision making. Patients will then be followed-up at 3-months via telephone call and electronic medical records review.

Institution
MUSC
Recruitment Contact
Dante Giovagnoli
8438764922
giovagnd@musc.edu

Human Samples Biorepository

Date Added
August 21st, 2018
PRO Number
Pro00072807
Researcher
Federica del Monte

List of Studies


Keywords
Aging, Cardiovascular, Coronary Artery Disease, Genetics, Heart, Military, Sarcoidosis, Scleroderma, Transplant, Vascular
Summary

The purpose of the study is to generate a bio bank of specimens for research. We will tissue that would otherwise be discarded from clinical or surgical procedure and information from medical records. We will also collect discarded blood, urines and sputum. Collecting samples will help to better understanding the mechanisms of cardiovascular diseases, identify biomarkers for early diagnosis and to predict safety and efficacy of new therapies.

Institution
MUSC
Recruitment Contact
Federica del Monte
843-792-8397
delmonte@musc.edu

The HEART Pathway: a learning health system project, translating evidence to practice across the Carolinas

Date Added
October 14th, 2016
PRO Number
Pro00059813
Researcher
Christine Carr

List of Studies


Keywords
Coronary Artery Disease, Heart
Summary

Current care patterns for patients with acute chest pain fail to provide optimal quality and value. To avoid missing acute
coronary syndrome (ACS), emergency physicians hospitalize >50% of patients who present to the Emergency Department with
chest pain. However, <10% are ultimately diagnosed with ACS, and this pervasive overtriage
costs $1013
billion annually.
The HEART Pathway, which was developed at Wake Forest Baptist Health (WFBH), is designed to improve care for patients with
chest pain. It uses a validated clinical decision aid and serial troponin measures to provide realtime
decision support to providers.
In our prior studies, the HEART Pathway decreased hospitalizations, stress testing, and hospital length of stay, without
increasing adverse events. These studies led to a learning health system project in collaboration with insurers, in which the
HEART Pathway was fully integrated into the WFBH EHR. Preliminary results demonstrate further reductions in hospitalizations
and stress testing. Given WFBH's success with the HEART Pathway, the next logical step is regional dissemination.
This project will leverage Carolinas Collaborative infrastructure to collect data specific to the HEART Pathway from all 4 health
systems, establishing rates of healthcare utilization and ACS outcomes for Emergency Department patients with chest pain in
the Carolinas. In addition, we will engage key stakeholders at each health system to develop an implementation strategy. This
proposal builds on our prior work and will provide pilot data essential for a larger grant application that will support rigorous
testing and implementation of the HEART Pathway across Carolinas Collaborative health systems.

Institution
MUSC
Recruitment Contact
Christine Carr
843-792-5038
carrc@musc.edu



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