Stroke Clinical Trials

Active Studies: Acute Stroke

AXIOMATIC-BMS
Condition studied: acute ischemic stroke, transient ischemic attack (TIA)
MASTERS-2- Athersys
Condition Studied: ischemic stroke
MOST Trial NIH/StrokeNET
Condition Studied: acute ischemic stroke
REDUCE PAS
Condition studied: ischemic stroke, patent foramen ovale (PFO)
SORT - Stroke and Artificial Intelligence (SORT) Screening Study
Condition studied: acute neurological symptoms, acute stroke, chronic stroke

Active Studies: Secondary Stroke Prevention

ARCADIA-NIH/StrokeNET
Condition studied: ischemic stroke
BUBL- Robotic TCD Ultrasound Bubble Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
Condition treated: embolic stroke of undetermined source (ESUS), transient ischemic attack (TIA), right-to-left atrial shunt, patent foramen ovale (PFO)
CREST-2 NIH/StrokeNET
Condition studied: carotid stenosis

Stroke Rehabilitation

Music Listening in Stroke Recovery
Condition studied: ischemic stroke

Pending Studies

RELIEF
Condition studied: migraine, patent foramen ovale (PFO)

Closed Studies

AXIOMATIC-BMS

A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Response-Adaptive Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Covert Brain Infarction in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA).

Study director (local PI): David Chiu, MD
Condition studied: acute ischemic stroke, transient ischemic attack (TIA)
ClinicalTrials.gov identifier: NCT03766581
IRB #: Pro00022059
IRB approval date: 08/22/2019
To learn more email David McCane at dmccane@houstonmethodist.org or call 713.441.5801

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MASTERS-2- Athersys

Multistem® Administration for Stroke Treatment and Enhanced Recovery Study. A Phase 3, randomized, double-blind, placebo-controlled, multicenter international study.

Study director (local PI): David Chiu, MD
Condition Studied: ischemic stroke
ClinicalTrials.gov identifier: NCT03545607
IRB #: Pro00019190
IRB approval date: 03/22/2018
To learn more email David McCane at dmccane@houstonmethodist.org or call 713.441.5801

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MOST Trial NIH/StrokeNET

Multi-arm Optimization of Stroke Thrombolysis (MOST): a blinded, randomized controlled adaptive, multi-arm, adjunctive-thrombolysis efficacy trial in ischemic stroke. Determine if argatroban or eptifibatide results in improved 90-day mRS as compared with placebo in acute ischemic stroke patients treated with IV rt-PA within three hours of symptom onset. Patients may also receive endovascular thrombectomy (ET) per usual care.

Study director (local PI): Vivek Misra, MD
Condition Studied: acute ischemic stroke
ClinicalTrials.gov identifier: NCT03735979
IRB #: Pro00020938
IRB approval date: 02/11/2019
To learn more email David McCane at dmccane@houstonmethodist.org or call 713.441.5801

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REDUCE PAS

Gore Cardioform Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patient Foramen Ovale (PFO): the REDUCE Post Approval Study.

Study director (National PI): John J. Volpi, MD
Study director (Local PI): Chun H. Lin, MD
Condition studied: ischemic stroke, patent foramen ovale (PFO)
ClinicalTrials.gov Identifier: NCT03821129
IRB #: Pro00021260
IRB approval date: 09/24/2019
To learn more email Amber Criswell at acriswell@houstonmethodist.org or call 346.238.5214.

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SORT - Stroke and Artificial Intelligence (SORT) Screening Study

This is a prospective screening study aimed to develop a rapid screening tool and artificial intelligence software to assist clinicians during triage for stroke. The study is actively enrolling both healthy volunteers and patients.

Study director (National PI): John J. Volpi, MD
Condition studied: acute neurological symptoms, acute stroke, chronic stroke
ClinicalTrials.gov Identifier: (None, not listed)
IRB #: Pro00020577
IRB approval date: 11/15/2018
To learn more email Amber Criswell at acriswell@houstonmethodist.org or call 346.238.5214.

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ARCADIA-NIH/StrokeNET

AtRial Cardiopathy and Antithrombotic Drugs in Prevention After cryptogenic stroke.

Study director (local PI): Vivek Misra, MD
Condition studied: ischemic stroke
ClinicalTrials.gov Identifier: NCT03192215
IRB #: Pro00019940
IRB approval date: 07/06/2018
Contact info: To learn more email David McCane at dmccane@houstonmethodist.org or call 713.441.5801

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BUBL- Robotic TCD Ultrasound Bubble Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt

Multi-center, prospective, single-arm, non-significant risk (NSR) device study in 150 patients with suspicion of embolic stroke of undetermined source.

Study director (National PI): John J. Volpi, MD
Condition treated: embolic stroke of undetermined source (ESUS), transient ischemic attack (TIA), right-to-left atrial shunt, patent foramen ovale (PFO)
ClinicalTrials.gov Identifier: NCT04604015
IRB #: Pro00026775
IRB approval date: 11/10/2020
To learn more email Amber Criswell at acriswell@houstonmethodist.org or call 346.238.5214.

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CREST-2 NIH/StrokeNET

Carotid Revascularization for Primary Prevention of Stroke.

Study director (local PI): David Chiu, MD
Condition studied: carotid stenosis
ClinicalTrials.gov Identifier: NCT02089217
IRB #: Pro00012292
IRB approval date: 02/25/2015
To learn more email David McCane at dmccane@houstonmethodist.org or call 713.441.5801

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Music Listening in Stroke Recovery

Music listening or spoken word listening for patients with following a 90-day listening schedule for patients with recent stroke within 30days to 1 year.

Study director (National PI): John J. Volpi, MD
Condition studied: ischemic stroke
ClinicalTrials.gov Identifier: NCT03608904
IRB #: Pro00015563
IRB approval date: 12/22/2016
To learn more email Jonathan Wiese at jrwiese@houstonmethodist.org or call 713.441.7161.

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RELIEF

GOREÂ® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to evaluate the safety and efficacy of transcatheter closure of patent foramen ovale for relief of migraine headaches. Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the Gore Cardioform Septal Occluder for migraine headache relief.

Study direction (Local PI): Chun H. Lin, MD
Condition studied: migraine, patent foramen ovale (PFO)
ClinicalTrials.gov Identifier: NCT04100135
IRB #: Pro00024894
IRB approval date: 09/08/2020
To learn more email Amber Criswell at acriswell@houstonmethodist.org or call 346.238.5214.

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ALIAS (NIH/Univ. of Miami) - Albumin in Acute Stroke Trial: A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke
ANCROD/ASP Trial (Neurobiological Technologies, Inc.) - A Randomized, Double-Blind, Placebo-Controlled Study of Viprinex™ (Ancrod Injection) in Subjects Beginning Treatment within 6 Hours of the Onset of Acute, Ischemic Stroke
ARC1779-008- (Archemix Corp.) -A Study of the Effect of ARC1779 Injection on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy
ARISTOTLE (Brystol-Meyers-Squibb) - A Large, multinational Phase III trial of a new oral anticoagulation medication in patients with atrial fibrillation
ARTSS-2 - A pilot, phase IIb, randomized, multi-center trial of Argatroban in combination with recombinant tissue plasminogen activator for acute stroke (1 hour from start of t-PA)
ASBI802-Asubio Pharmaceuticals-a basic fibroblast growth factor agonist. The drug will be administered between 24 and 48 hours following the onset of a non-hemorrhagic, large vessel stroke with a moderately severe motor deficit. Initially, the drug will be administered intravenously, but once it is established that the patient is able to swallow, the drug will be switched to a liquid oral formulation, and administered for 28 days
ASSENT- Daiichi Sankyo- A Phase 1b/2, Multi-Center, Double-Blind (Principal Investigators and Study Subjects Blinded, Sponsor Unblinded), Placebo-Controlled, Randomized, Single-Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects with Acute Ischemic Stroke.
ATACH-II-NIH/NINDS- A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage
AtriCure- Feasibility Clinical Investigation of a Minimally Invasive Surgically Deployed Atricure Atriclip Left Atrial Appendage Exclusion System for Stroke Prophylaxis in Patients with Non-Valvular Atrial Fibrillation and in Whom Long Term Oral Anticoagulation Therapy is Medically Contraindicated
AVENTIS/PREVAIL -A double-blind, randomized, parallel-group, multi-center, study to evaluate the efficacy and safety of Enoxaparin versus unfractionated Heparin in the prevention of venous thromboembolism in patients following acute ischemic stroke
Bayer-Ingentix/MRECT - A randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, tolerability, and pharmacokinetic/pharmacodynamic effects of a neuroprotectant repinotan HCl in patients with acute ischemic stroke (enrollment ended 6/16/04)
CHANT/AstraZeneca NXY-0012 - A double-blind, randomized, placebo-controlled, parallel group, multicenter, phase IIb study to assess the safety and tolerability of 72 hours intravenous infusion of NXY-059 in adult patients with intracerebral hemorrhage (ICH)
CLOSURE I (NMT Medical) - A prospective, multi-center, randomized controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with stroke and/or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale
CoBIS 2-Trial- Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke - IND 16274. This is a multicenter, placebo-controlled, randomized, double-blinded Phase 2 study in 100 subjects 18-90 years of age who have sustained a recent ischemic stroke.
CoBIS-Trial- Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke-IND16274
COSS-(NIH) -Carotid Occlusion Surgery Study
CREST-ABBOTT VASCULAR-(NIH/UMDNJ) Carotid Revascularization Endarterectomy vs. Stent Trial
DALF-PS-1016-Acordia- A phase III, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two dose strengths of dalfampridine Extended-Release capsules for once daily administration on stable walking deficits in post-ischemic stroke
DALF-PS-1029-Acordia Extention study- Extension study providing active medication in two dose strengths to patients who have completed the MILESTONE placebo-controlled study, for one year or until the study is closed
DIAS-2/Paion/Forest Research Institute - A Prospective, Randomized, Double-Blind, Placebo-Controlled, Single Bolus, Multinational, Multi-Center, Parallel Group, Dose-Ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke
DIAS-4 – (Lundbeck) A randomized, double-blind, parallel-group placebo-controlled phase lll study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke
EPIC/SPI-103/Daiichi Asubio- A Phase IIb Randomized, Double-Blind, Placebo-Controlled, Group-Sequential, Multicenter, Dose Finding Study of the Safety and Efficacy of SUN N4057 (Piclozotan) Administered for 72 Hours by Continuous Intravenous Infusion in Subjects with Acute Ischemic Stroke and Measurable Penumbra on MRI
ESIS - A Phase IV multi-center, observational study designed to collect cross-sectional data on selected demographics, practice patterns, and health outcomes for t-PA treated stroke patients (Completed March 04)
GENES (NIH/Univ. of BC)- (an SPS3 sub-study)
Harmony Exoskeleton in Post Stroke Patients-HMH/UT-Austin- The study will provide an enhanced understanding of dynamics of the human hand and arm, and help to develop design guidelines for robotic exoskeleton for hand and arm rehabilitation in post-stroke patients. IRB(Pro00014231)
IMPACT-24A (BrainsGate) (IMPlant Augmenting Cerebral Blood Flow Trial 24 hours from stroke onset) A Multicenter, Randomized, Double-Blind, Sham Control, Parallel Arm Trial to Assess Safety and Effectiveness of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects with Acute Ischemic Stroke
IMPACT-24B (BrainsGate) - (IMPlant Augmenting Cerebral Blood Flow Trial 24 hours from stroke onset) A Multicenter, Randomized, Double-Blind, Sham Control, Parallel Arm Trial to Assess Safety and Effectiveness of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects with Acute Ischemic Stroke 24 hour window
IRIS (NIH/YALE) Insulin Resistance Intervention after Stroke Trial
MACSI-(DPharm) -Membrane-Activated Chelator Stroke Intervention. A double-blind, randomized, placebo-controlled, parallel group, multicenter Phase 3 pivotal study to assess the safety and efficacy of 1mg/kg/day intravenous DP-b99 over 4 consecutive days versus placebo when initiated within nine hours of acute ischemic stroke onset
MaRISS- AHA/UofMiami- Mild and Rapidly Improving Stroke Study- To elucidate long-term outcomes of patients with mild and rapidly improving stroke and examine the association with tPA treatment.
MASTERS-1-Multistem (Athersys) Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke 24-36 hour window
Mobile Stroke Unit -Comparison of pre-hospital treatment of acute ischemic stroke in a mobile van, according to FDA approved labeling and standard of care protocol, versus treatment in the emergency department after arrival at the hospital. Time to treatment and 90-day outcome are the main endpoints.
MoSIS-(NIH/Univ. of Miami) - Mechanisms of Stroke in Intracranial Stenosis (a SAMMPRIS Sub-study)
MP-124-A01(Mitsubishi Tanabe Pharma) - A Phase I Double-Blinded, Placebo-Controlled, Ascending-Dose, Clinical Study Investigating the Safety, Tolerability, and Pharmacokinetics of the investigational drug in Acute Ischemic Stroke patients
NAVIGATE-ESUS- Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS), comparing rivaroxaban 15 mg once daily with aspirin 100 mg (NAVIGATE ESUS) IRB (Pro00015901) NCT 02313909
NEST-2/NeuroTheraâ (PhotoThera) - Effectiveness and Safety Trial – 2. A double-blind, randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of the treatment of acute ischemic stroke with the NeuroTheraâ Laser System within 24 hours from stroke onset.
NEST-3 (PhotoThera) NeuroThera® Efficacy and Safety Trial - 3 (NEST-3) A double-blind, randomized, sham-controlled, parallel group, multicenter, pivotal study to assess the safety and efficacy of transcranial laser therapy with the NeuroThera® Laser System for the treatment of acute ischemic stroke within 24 hours of stroke onset 24 hour window
ONO-Omnicare/RREACT - Placebo-controlled evaluation of neuroprotectant ONO-2506 intravenous infusion in subjects with acute ischemic stroke
ONTARGET/TRANSCEND -ONTARGET- Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial: A large simple randomized trial of an angiotension II receptor antagonist (Telmisartan) an ACE-Inhibitor (Ramipril) in patients at high risk for cardiovascular events. Parallel study: TRANSCEND- Telmisartin Randomized Assessment Study in ACE intolerant subjects with cardiovascular Disease (enrollment ended) follow-up continues
PARFAIT-CV006004-Bristol-Myers Squibb, Inc. -A Phase 2, Placebo-Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of BMS-986141 For the Prevention of Recurrent Brain Infarction in Subjects receiving acetylsalicylic acid (ASA) following Acute Ischemic Stroke or Transient Ischemic Attack
Pfizer-A9541004 - a phase 2 multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of pf-03049423 in subjects with ischemic stroke. 24-72 hour window
POINT (NIH/UCSF)-Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (12 hours from LKN) IRB (Pro00005976) NCT 00991029
PREMIUM Trial-(AGA Medical) (Prospective Randomized investigation to Evaluate incidence of headache reduction in subjects with Migraine and PFO Using the AMPLATZER PFO Occluder compared to Medical Management
PRISMS-Genentech, Inc.- A Phase IIIB, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients with Mild Stroke (Rapidly Improving Symptoms and Minor Neurologic Deficits) (3 hours from LKN)
PROFESS/BI - PRoFESS- Prevention Regimen For Effectively avoiding Second Strokes: A double-blind, active and placebo-controlled study of Aggrenox vs. Clopidogrel + aspirin, with and without Micardis 1/17/2006
REDUCE Study-(W. L. GORE) - Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients with Patent Foramen Ovale (PFO)
RESPECT-ESUS-BI-A phase III, randomized, double-blind evaluation in secondary stroke prevention comparing the efficacy and safety of the thrombin inhibitor dabigatran etexiate 110 or 150mg (twice daily) versus acetylsalicylic acid (100 mg once daily) in patients with embolic stroke of undetermined source (RE-SPECT ESUS) IRB (Pro00011844) NCT02239120
SAINT II/AstraZeneca NXY-0007 - A double-blind, randomized, placebo-controlled, parallel group, multicenter, phase IIb/III study to assess the efficacy and safety of intravenous NXY-059 in acute ischemic stroke
SAMMPRIS-(NIH/MUSC)- Stenting versus Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis
SENTIS- (CoAxia) - NeuroFlo Cerebral Perfusion Augmentation Catheter acute stroke therapy
SOCRATES-AstraZeneca- A Randomized, Double-Blind, Multinational Study to Prevent Major Vascular Events with Ticagrelor Compared to Aspirin (ASA) in Patients with Acute Ischemic Stroke or TIA (24 hours from LKN)
SPS3 (NIH/Univ. of BC) - Secondary Prevention of Small Subcortical Strokes
Stroke AF-Medtronic-A prospective, multi-site, randomized, non-blinded, post-market study. The Stroke AF study will characterize the incidence rate of AF through 12 months in subjects with a recent ischemic stroke of presumed known origin. Subjects will have a Reveal LINQ™ Insertable Cardiac Monitor (ICM) inserted within 10 days of the stroke and undergo continuous remote monitoring.
Suntory-SCRIEX/SPI102 - A phase II, randomized, double-blind, placebo-controlled, escalating dose study of a neuroprotectant SUN N4057 in successive cohorts of patients with acute ischemic stroke (enrollment ended 5/11/04)
THERAPY Trial-(Penumbra Inc.) - The Randomized, Concurrent Controlled Trial to Assess the Penumbra System’s Safety and Effectiveness in the Treatment of Acute Stroke
TMPRS-HMH- Multifocal brain magnetic stimulation in chronic ischemic stroke.
TRA2P/TIMI50 - A multicenter, randomized, Double-Blind, Placebo-Controlled Study to Evaluate the safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events treatment and 90-day outcome are the main endpoints.
TUCSON -A Phase 1-2, Randomized, Placebo-Controlled, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 with Continuous Ultrasound Administration in Subjects with Acute Ischemic Stroke Receiving Treatment with Intravenous Tissue Plasminogen Activator.
VASTT/Canadian Stroke Consortium - A Phase II, Multi-Centre, Two-Part Study to Evaluate the Safety and Efficacy of V10153 in Acute Ischaemic Stroke. Part A – An Open-Label, Dose Escalation, Single-Dose Administration Evaluation of the Safety of Four Dose Levels of V10153. Part B – A Randomised, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of a Single Dose of V10153

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Stroke Clinical Trials

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GME Fellowship

Affiliated Department

AXIOMATIC-BMS

MASTERS-2- Athersys

MOST Trial NIH/StrokeNET

REDUCE PAS

SORT - Stroke and Artificial Intelligence (SORT) Screening Study

ARCADIA-NIH/StrokeNET

BUBL- Robotic TCD Ultrasound Bubble Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt

CREST-2 NIH/StrokeNET

Music Listening in Stroke Recovery

RELIEF

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