Carotid Revascularization and Medical Management for Asymptomatic Carotid stenosis - Hemodynamics (CREST-H) Save

Date Added
January 31st, 2018
PRO Number
Pro00073070
Researcher
Christine Holmstedt

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Keywords
Cardiovascular, Heart, Stroke
Summary

This is an ancillary study on the Phase 3 parent trial (CREST-2) in which patients with asymptomatic high grade carotid artery stenosis have enrolled to receive either a novel intensive medical management plan alone, or in combination with either Carotid Endarterectomy (CEA) or Carotid artery stenting (CAS). Patients enrolled in CREST-H will undergo a baseline MRI and some patients will also undergo a followup MRI at 1 year. The purpose is to determine whether cognition can be improved by revascularization among the subset of CREST-2 patients with hemodynamic impairment and mild cognitive impairment at baseline.

Institution
MUSC
Recruitment Contact
Cheryl Grant
843-792-7118
grantche@musc.edu

AtRial Cardiopathy and Antithrombotic Drugs in prevention After cryptogenic stroke Save

Date Added
January 10th, 2018
PRO Number
Pro00072371
Researcher
Christine Holmstedt

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Profiles_link
Keywords
Cardiovascular, Heart, Hypertension/ High Blood Pressure, Stroke, Stroke Recovery
Summary

ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban (Eliquis) versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. 1100 subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.

Institution
MUSC
Recruitment Contact
Cheryl Grant
843-792-7118
grantche@musc.edu

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard-of-Care Study of n-Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke in Adult Subjects Save

Date Added
November 28th, 2017
PRO Number
Pro00072723
Researcher
Christine Holmstedt

List of Studies


Profiles_link
Keywords
Stroke
Summary

Protocol Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard-of-Care Study of n-Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke in Adult Subjects. The purpose of this study is to evaluate the safety of NBP treatment compared with placebo in subjects with mild to moderate acute ischemic stroke (AIS). Male and female adult subjects between 18-80 years will participate. Approximately 400 eligible subjects will be enrolled study wide at multiple sites. Subjects will participate in the study for 90 days includng a 30-day drug treatment period and a 60-day follow-up period, or until a discontinuation criterion is met.

Institution
MUSC
Recruitment Contact
Cheryl Grant
843-792-7118
grantche@musc.edu

Management of Acute Stroke Patients on Treatment with New Oral Anticoagulants: Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) Registry Save

Date Added
July 20th, 2016
PRO Number
Pro00048033
Researcher
Christine Holmstedt

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Profiles_link
Keywords
Stroke
Summary

The ARAMIS registry is designed to provide important and timely insight into the management of acute stroke patients who are on NOA in community practice. The primary goal is to address several key treatment and management issues surrounding patients with either AIS or ICH on anticoagulant therapy. In particular, attention will be focused on coagulation tests, utilization of thrombolytic therapy
for AIS, treatment patterns and clinical outcomes for AIS and ICH patients on anticoagulant therapy. The acquisition of such findings will be of critical importance to help fill in gaps on guideline recommendations and provide insights into the management of AIS and ICH patients on treatment with
new anticoagulants. This will allow physicians to feel more confident in anticoagulation therapy while improving the care and outcomes of patients on these agents who have stroke complications.

Institution
MUSC
Recruitment Contact
Nancy Turner
843-792-1468
turnern@musc.edu

CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL Save

Date Added
July 6th, 2015
PRO Number
Pro00043906
Researcher
Christine Holmstedt

List of Studies


Profiles_link
Keywords
Stroke
Summary

CREST-2 is two parallel multi-center randomized, observer-blinded endpoint clinical trials. One trial will assess treatment differences between intensive medical management alone compared to carotid endarterectomy procedure plus intensive medical management. The parallel trial will assess treatment differences between intensive medical management alone compared to carotid artery stenting plus intensive medical management. Intensive medical management will involve control of blood pressure, LDL cholesterol, cigarette smoking, and other vascular risk factors.

Institution
MUSC
Recruitment Contact
Robert Burfeind
843-792-8606
burfeind@musc.edu

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