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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Jacksonville, FL
The primary purpose of this study is to determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).
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A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
Jacksonville, FL
The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).
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Prolonged Cardiac Monitoring in Individuals with High Risk for Atrial Fibrillation and Stroke
Jacksonville, FL
The purpose of this study is to screen high-risk subjects with annual prolonged cardiac monitoring to determine the rate of subclinical atrial fibrillation detection.
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Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Rochester, MN
The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.
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A Study of Clopidogrel for the Prevention of TIA and Minor Ischemic Stroke
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effectiveness of Clopidogrel for preventing the occurance of transient ischemic attacks (TIA) and minor strokes.
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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Scottsdale/Phoenix, AZ
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
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Stroke Mitigation in A-fib Reasoning Tool for Shared Decision Making
Rochester, MN
The purpose of this study is to assist patients and clinicians weigh the potential harms and benefits of different treatment options for atrial fibrillation. The plan is to develop an evidence-based decision aid for use in clinical encounters. The goal is to promote evidence-based patient-centered care. Ideally, this care should reflect the research evidence about treatment options for atrial fibrillation. It should also reflect the values and preferences of the informed patient.
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Sleep for Stroke Management and Recovery Trial
Scottsdale/Phoenix, AZ
The primary objectives of this study are to determine whether treatment of OSA with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
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A Study to Evaluate Decision-support Interventions for Atrial Fibrillation (RED-AF)
Rochester, MN
- The primary purpose of this study is to assess the comparative effectiveness of the following 4 approaches to promote high-quality SDM for at-risk patients with AF: a PDA alone, (2) an EDA alone, (3) a combination of a PDA and an EDA, and (4) control with neither a PDA nor an EDA.
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A Study to Evaluate Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals
Eau Claire, WI; Rochester, MN; La Crosse, WI
The purpose of this study is to determine if an atrial fibillation (AF) detection intervention in men and women at least 70 years of age with undiagnosed AF or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).
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AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Rochester, MN
Objectives - Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. - Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
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CREST-2 Randomized Clinical Trial (C2LOE)
Jacksonville, FL
The purpose of this study is to compare the post-procedure treatment differences in stroke risk between those randomized to revascularization and intensive medical management (IMM) and those randomized to IMM alone.
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A Study Comparing Apixaban to Vitamin K Antagonist for the Prevention of Stroke or Systemic Embolism and Bleeding in Patients with Non-valve Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if apixaban given for 6 months is safer than Vitamin K Antagonist (VKA) given for 6 months in terms of major bleeding and non-major bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or in atrial fibrillation patients undergoing a procedure to open up a blood vessel in the heart (percutaneous coronary intervention). All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel). All patients would be treated for an intended 6 months.
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A Post-Approval Study of the Pivotal Cohort Extended Follow-Up for MOMENTUM 3
Rochester, MN
The primary purpose of this study is to report the composite endpoint of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump at 5-years post-implant in subjects who were implanted with the HM3 or HMII LVAS in the MOMENTUM 3 IDE trial and are ongoing at the 2-year follow-up.
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A Study to Evaluate Sleep for Stroke Management and Recovery
Rochester, MN
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)
Jacksonville, FL; Rochester, MN
We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral ...
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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Jacksonville, FL; Rochester, MN
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
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A Study Comparing Carotid Revascularization Endarterectomy Versus Stenting
Jacksonville, FL
The purpose of this study is to compare the relatively new procedure of stent-assisted carotid angioplasty to the traditional and accepted surgical approach of carotid endarterectomy for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).
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Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on Recovery (DISCOVERY)
Rochester, MN
The purpose o fthis study
A total of 8,000 patients presenting to CPSs with acute-onset AIS, ICH or aSAH and no history of dementia will be enrolled within 6 weeks of stroke onset.
All participants will undergo baseline screening for evidence of pre-stroke dementia. Those who pass baseline screening will complete a blood draw and a series of cognitive and functional assessments at baseline.
Participants will undergo in-person (3-6 months, 18 months) and telephone (annual) follow-up visits for the duration of the study to assess for longitudinal cognitive and functional outcomes. In addition to Tier 1 procedures, at each in-person follow-up visit: Tier ...