Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery (ASPIRE)

Date Added
October 7th, 2019
PRO Number
Pro00092649
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The purpose of the study is to compare the effects of apixaban (also known as Eliquis®) with aspirin in patients with atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

Subjects will be in the research study for up to 3 years (minimum of 1 year). About 700 people will take part in this study at approximately 125 sites throughout the United States.

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

Coordinated, Collaborative, Comprehensive, Family-Based, Integrated, and Technology-Enabled Care: A Comparative Effectiveness Randomized Trial To Improve Stroke Care Delivery

Date Added
September 24th, 2019
PRO Number
Pro00090574
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

C3FIT is a randomized trial to determine the most effective way for hospitals to take care of stroke patients after they are discharged by comparing two plans. Plan 1 is the usual standard of care way performed at Comprehensive/Primary Stroke Centers and developed by the Amercian Heart Association and the Joint Comissiona. Plan 2 is the same as Plan 1 PLUS in-home rehabilitation. MUSC has been selected as a study site for Plan 1 only.

Patients over the age of 18 with a clinical diagnosis of acute stroke with brain imaging with intracerebral hemorrhage or ischemic stroke are eligible who meet addtional study qualification requirements. Total duration of participation is 2 years. Study enrollment will be performed at approximately 18 sites for a total enrollment goal of 1800 patients, 100 per site.

Data from C3FIT may be used to help identify the best methods for health systems to use in managing stroke patients.

Institution
MUSC
Recruitment Contact
Ariana Tinker
843-792-6881
tinkera@musc.edu

ARCADIA-CSI (Cognition and Silent Infarcts)

Date Added
July 31st, 2019
PRO Number
Pro00091520
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

This is a research study looking to compare the effects (good and bad) of the ARCADIA study drugs (apixaban and aspirin) on the occurrence of silent strokes and memory loss after stroke.

This add-on study to the ARCADIA trial involves cognitive testing (tests designed to measure subjects memory, thinking, reasoning and understanding) and an MRI scan of their brain.

There will be about 5 study visits over the length of the study (approximately 3 years), or for a long as subjects are in the parent ARCADIA study.

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

Sleep for Stroke Management and Recovery Trial

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

List of Studies


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

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

List of Studies


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)

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

List of Studies


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
Vicki Streets
843-792-8606
streetsv@musc.edu

AtRial Cardiopathy and Antithrombotic Drugs in prevention After cryptogenic stroke

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

List of Studies


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 6 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 7 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
Vicki Streets
843-792-8606
streetsv@musc.edu

CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL

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

List of Studies


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
Vicki Streets
843-792-8606
streetsv@musc.edu



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