Research & Clinical Trials


 



Active Studies

 

Acute Stroke Trials

 

POINT (NIH/UCSF) Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke

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.

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.

 

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Secondary Stroke Prevention Trials

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.


CREST-2 Carotid Revascularization for Primary Prevention of Stroke

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)

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)

 


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Stroke Rehabilitation

TMPRS-HMH-Multifocal brain magnetic stimulation in chronic ischemic stroke

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. 

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.

 

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Completed stroke trials

Listing below is a history of stroke clinical trials that Houston Methodist has participated in.

 

CoBIS-Trial- Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke-IND16274

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)

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

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

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

CREST-ABBOTT VASCULAR-(NIH/UMDNJ) Carotid Revascularization Endarterectomy vs. Stent Trial 

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)

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 hour from LKN)

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 

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 Contrindicated

IRIS (NIH/YALE)  Insulin Resistance Intervention after Stroke Trial

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

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

THERAPY Trial-(Penumbra Inc.)- The Randomized, Concurrent Controlled Trial to Assess the Penumbra System’s Safety and Effectiveness in the Treatment of Acute 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 

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 

SAMMPRIS-(NIH/MUSC)- Stenting versus Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis

SPS3 (NIH/Univ. of BC)  Secondary Prevention of Small Subcortical Strokes

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

GENES (NIH/Univ. of BC)- (a SPS3 sub-study)

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

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

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

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

MoSIS-(NIH/Univ. of Miami)-Mechanisms of Stroke in Intracranial Stenosis (a SAMMPRIS Sub-study)

ARISTOTLE (Brystol-Meyers-Squibb)- A Large, multinational Phase III trial of a new oral anticoagulation medication in patients with atrial fibrillation

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

COSS-(NIH)-Carotid Occlusion Surgery Study

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 

ARC1779-008- (Archemix Corp.) A Study of the Effect of ARC1779 Injection on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy

SENTIS- (CoAxia)  NeuroFlo Cerebral Perfusion Augmentation Catheter acute stroke therapy

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 

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

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

NEST-2/NeuroTheraâ (PhotoThera) Effectiveness and Safety Trial – 2.  A double blind, randomized, controlled, parallel group, muliticenter, 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.

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

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   

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.

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  

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 

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 

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)    

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   

ONO-Omnicare/RREACT   Placebo controlled evaluation of neuroprotectant ONO-2506 intravenous infusion in subjects with acute ischemic stroke

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)

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)

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)

 

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