Sleep for Stroke Management and Recovery Trial Save

Date Added
June 4th, 2019
PRO Number
Pro00088514
Researcher
Christine Holmstedt

List of Studies


Profiles_link
Keywords
Sleep Disorders, Stroke, Stroke Recovery
Summary

This research is being done to figure out whether treatment for sleep apnea, in people who have had a stroke or TIA, improves recovery from stroke, and helps prevent future stroke, heart problems, and death.

The intervention being tested is called continuous positive airway pressure (CPAP). The U.S. Food and Drug Administration (FDA) has approved CPAP for the treatment of obstructive sleep apnea.

A total of 15,010 patients are expected to enroll in this study and be screened for sleep apnea across about 110 sites in the United States. About 3,000 are expected to participate in the second part of the study, in which sleep apnea treatment is tested. Participation in this study is approximately 6 months.

Institution
MUSC
Recruitment Contact
Vicki Streets
843-792-8606
streetsv@musc.edu

A Phase III, Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Thrombolysis in Imaging-Eligible, Late-Window Patients To Assess the Efficacy and Safety of Tenecteplase Save

Date Added
March 26th, 2019
PRO Number
Pro00086659
Researcher
Christine Holmstedt

List of Studies


Profiles_link
Keywords
Stroke
Summary

The purpose of this research study is to evaluate the desired outcome and safety of the study drug, tenecteplase, compared to a placebo in patients with an acute ischemic stroke. Tenecteplase is approved by the health authorities for the treatment of heart attack, but it is not approved for stroke.

Participants will be screened within 4.5 to 24 hours after the onset of the stroke and will undergo 2 followup MRIs within 96 hours.

Follow-up clinic visits will occur at 30 and 90 days after study treatment. Total study duration is about 3 months.

Institution
MUSC
Recruitment Contact
Vicki Streets
(843)-792-8606
streetsv@musc.edu

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

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

List of Studies


Profiles_link
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

List of Studies


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

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

Change_preferences

-- OR --

Create_login