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 Healthcare
Recruitment Contact
Heather Rich
8649432416
heather.rich@selfregional.org

Assessment of cortical network connectivity in individuals with impaired walking coordination post-stroke

Date Added
July 6th, 2021
PRO Number
Pro00111026
Researcher
Steven Kautz

List of Studies


Keywords
Muscle, Non-interventional, Rehabilitation Studies, Stroke Recovery
Summary

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method often used to assess connectivity between the brain and specific muscles. This research study is aimed at finding the changes in the manner brain communicates with leg muscles post-stroke and its effects on movement coordination during walking.

Institution
MUSC
Recruitment Contact
Shraddha Srivastava
8437926165
srivasts@musc.edu

Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)

Date Added
August 26th, 2021
PRO Number
Pro00111341
Researcher
Cynthia Dodds

List of Studies


Keywords
Brain, Infant, Movement Disorders, Pediatrics, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Constraint-induced movement therapy (CIMT) is the most efficacious treatment for children with hemiparesis from a perinatal arterial stroke but instead, weekly low-dose OT and/or PT is typical. The aims of this study are to compare 2 high doses of treatment to usual care in helping infants improve skills on the hemiplegic hand/arm and to improve bimanual activities. In addition, the association with gross motor, language and cognition will be explored.

Institution
MUSC
Recruitment Contact
Patricia Coker-Bolt
843-792-7491
cokerpc@musc.edu

Feasibility of Using Maestro Hand Exoskeleton in Post-stroke Hand Rehabilitation to Improve Joint Coordination

Date Added
September 7th, 2021
PRO Number
Pro00112509
Researcher
Na Jin Seo

List of Studies


Keywords
Physical Therapy, Stroke, Stroke Recovery
Summary

Approximately 80% of stroke survivors have hand impairment. A majority do not fully recover their hand function despite completing standard rehabilitation. Limited hand function results in learned non-use not only of the hand but also of the whole arm. This limited upper limb movement results in decreased independence and poor quality of life. It is known that training for proper movement patterns is important especially early in rehabilitation. The purpose of this project is to determine if training using hand exoskeleton to improve finger movement is feasible in stroke patients. Stroke survivors will receive training with 4 different control strategies to improve finger joint coordination.

Institution
MUSC
Recruitment Contact
Kristen Coupland
843-792-7685
coupland@musc.edu

Cranial-nerve non-invasive neuromodulation and dynamic balance in chronic stroke survivors

Date Added
September 7th, 2021
PRO Number
Pro00113565
Researcher
Steven Kautz

List of Studies


Keywords
Rehabilitation Studies, Stroke Recovery
Summary

Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training and breathing exercises improves walking stability post-stroke.

Institution
MUSC
Recruitment Contact
Shraddha Srivastava
843-792-6165
srivasts@musc.edu

Validation of Early Prognostic Data for Recovery Outcome after Stroke for Future, Higher Yield Trials

Date Added
December 8th, 2021
PRO Number
Pro00116137
Researcher
Kirstin-Friederike Heise

List of Studies

Keywords
Rehabilitation Studies, Stroke, Stroke Recovery
Summary

VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. The central hypothesis is that patients have different UE outcomes depending on corticomotor system (CMS) function, measured as motor evoked potential (MEP) status with TMS, and on CMS structure, measured as acute lesion load with MRI. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, TMS, and MRI measures in the acute stroke time window.

Institution
MUSC
Recruitment Contact
Patricia Finetto
843-792-8533
piersonp@musc.edu

Community use of wearable wrist stimulation device

Date Added
April 5th, 2022
PRO Number
Pro00118317
Researcher
Na Jin Seo

List of Studies


Keywords
Cerebral Palsey, Stroke, Stroke Recovery
Summary

Sensory stimulation has been shown to enhance rehabilitation outcomes. However, most sensory stimulation devices interfere with natural hand tasks. Thus, a new wearable stimulation device has been developed to deliver imperceptible vibration to wrist skin. This study is to evaluate the community use of the device for patients with neurologic movement disorders. Participation will include wearing the provided device and charging the device every night. The knowledge regarding community use of the device may contribute to improving the device functionality and usability for future users of the device.

Institution
MUSC
Recruitment Contact
Na Jin Seo
8437920084
seon@musc.edu

Enhanced Study Recruitment for Stroke Survivors through Longitudinal Data Collection in Multiple Domains

Date Added
April 5th, 2022
PRO Number
Pro00119024
Researcher
Alyssa Chesnutt

List of Studies

Keywords
Military, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

People who experience a stroke often have problems performing many different tasks during daily life. Most studies investigating stroke recovery and rehabilitation focus only on one type of task. The purpose of this research study is to measure individuals' function in many areas that can be affected by a stroke, such as their balance, mood, memory, reaching, and speech. This study will also track changes that can occur with task performance over time.

Institution
MUSC
Recruitment Contact
Alyssa Chesnutt
843-792-8171
hydar@musc.edu

Developing a Novel Cognitive-Behavioral Intervention for Psychosocial Rehabilitation in Chronic Stroke

Date Added
June 6th, 2022
PRO Number
Pro00118778
Researcher
Lisa McTeague

List of Studies


Keywords
Anxiety, Depression, Stress Disorders, Stroke Recovery
Summary

The purpose of this study is to identify domains in which stroke suvivors may have struggled since experiencing a stroke. These include things like emotional, family and work function. This study entails an interview and questionnaires that ask about functioning in these areas.

The longer-term goal of this work is to identify areas these areas so that we can develop a psychotherapy that could be helpful for individuals recovering from and living with the aftermath of stroke.

Institution
MUSC
Recruitment Contact
Lisa McTeague
843-792-8274
lisa.mcteague@va.gov

Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis

Date Added
June 30th, 2022
PRO Number
Pro00121190
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The purpose of this research study is to see whether ticagrelor and aspirin or rivaroxaban and aspirin compared to clopidogrel and aspirin will have the most success in preventing another stroke, bleed in the brain, or death in participants who have already had a stroke from a narrowed brain artery.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
8437928606
lemattyc@musc.edu



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