Strategy for Improving Stroke Treatment Response

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: Translational Sciences, Inc.
Study ID: NCT05948566
Phase: PHASE2
Status: Recruiting

Apply to this trial

Conditions

Ischemic Stroke

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

TS23 — BIOLOGICAL
Monoclonal antibody

Study Details

SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke.

Key Dates

Start date: Mar 18, 2024
Status verified: Jun 2026
Primary completion: Jul 31, 2027
Completion: Dec 31, 2027

Study Design

Enrollment: 300 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Placebo Comparator: Placebo
Placebo
Experimental: Dose 1 TS23
low dose
Experimental: Dose 2 TS23
next higher dose
Experimental: Dose 3 TS23
next higher dose
Experimental: Dose 4 TS23
highest dose

Primary Outcome Measure

The proportion of patients with ANY intracerebral hemorrhage (ICH) [ Time Frame: At 30 (+/- 4) hours after study drug ]

Central Contacts

Rebeca Aragon Garcia, BS, CCRC
9736688644
[email protected]
Pam Plummer, MSN,RN, CCRC
5138852437
[email protected]

Locations (52)

Facility	City	State	ZIP	Site coordinators
University of Alabama Hospital	Birmingham	Alabama	35233	Felix Guerra Castanon, MD [email protected] Felix Guerra Castanon, MD (PRINCIPAL_INVESTIGATOR)
Banner University Medical Center	Phoenix	Arizona	85006	Savdeep Singh, MD [email protected] Savdeep Singh, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Phoenix	Phoenix	Arizona	85054	-
Banner University Medical Center - Tucson	Tucson	Arizona	85719	Firas Kaddouh, MD, MHS [email protected] Firas Kaddouh, MD, MHS (PRINCIPAL_INVESTIGATOR)
UCSD Health La Jolla	La Jolla	California	92093	Maryo Jajo [email protected] Royya Modir, MD [email protected] Royya Modir, MD (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente Los Angeles	Los Angeles	California	90027	Navdeep Sangha, MD [email protected] Navdeep Sangha, MD (PRINCIPAL_INVESTIGATOR)
Sutter Medical Center	Sacramento	California	95816	-
UCSD Medical Center- Hillcrest Hospital	San Diego	California	92103	Maryo Jajo [email protected] Royya' Modir, MD [email protected] Royya Modir, MD (PRINCIPAL_INVESTIGATOR)
Hartford Hospital	Hartford	Connecticut	06102	Ajay Tunguturi, MD [email protected] Ajay Tunguturi, MD (PRINCIPAL_INVESTIGATOR)
Yale New Haven Hospital	New Haven	Connecticut	06511	James Giles, MD, PhD [email protected] James Giles, MD, PhD (PRINCIPAL_INVESTIGATOR)
Christiana Hospital	Newark	Delaware	19718	Jason Nomura, MD [email protected] Jason Nomura, MD (PRINCIPAL_INVESTIGATOR)
UF Health Shands Hospital	Gainesville	Florida	32608	-
Jackson Memorial Hospital	Miami	Florida	33136	Andrea Escobar [email protected] Gillian Gordon Perue, MD, MBBS, DM [email protected] Gillian Gordon Perue, MD, MBBS, DM (PRINCIPAL_INVESTIGATOR)
Grady Memorial Hospital	Atlanta	Georgia	30303	Nicolas Bianchi, MD [email protected] Nicolas Bianchi, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical Center	Chicago	Illinois	60637	James Siegler, MD, FAHA [email protected] James Siegler, MD, FAHA (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals & Clinics	Iowa City	Iowa	52242	-
Baptist Healthcare System, Inc.	Lexington	Kentucky	40503	Murali Kolikonda, MD [email protected] Franklin Echevarria [email protected] Murali Kolikonda, MD (PRINCIPAL_INVESTIGATOR)
University of Louisville Hospital	Louisville	Kentucky	40202	Isaac Abecassis, MD [email protected] Isaac Abecassis, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's Hospital	Boston	Massachusetts	02115	Rahul Mahajan, MD, PhD [email protected] Rahul Mahajan, MD, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital	Boston	Massachusetts	02171	Aneesh Singhal, MD, MBBS [email protected] Aneesh Singhal, MD, MBBS (PRINCIPAL_INVESTIGATOR)
M Health Fairview Ridges Hospital	Burnsville	Minnesota	55337	Jessica Staloch [email protected] Muhammad Affan, MD, MBBS [email protected] Muhammad Affan, MD, MBBS (PRINCIPAL_INVESTIGATOR)
M Health Fairview Southdale Hospital	Edina	Minnesota	55435	Jessica Staloch [email protected] Muhammad Affan, MD,MBBS [email protected] Muhammad Affan, MD, MBBS (PRINCIPAL_INVESTIGATOR)
M Health Fairview University of Minnesota Medical Center	Minneapolis	Minnesota	55455	Jessica Staloch [email protected] Muhammad Affan, MD,MBBS [email protected] Muhammad Affan, MD,MBBS (PRINCIPAL_INVESTIGATOR)
United Hospital	Saint Paul	Minnesota	55102	-
Barnes Jewish Hospital	St Louis	Missouri	63110	Charles Kircher, MD [email protected] Charles Kircher, MD (PRINCIPAL_INVESTIGATOR)
JFK Medical Center	Edison	New Jersey	08837	Nancy Gadallah, DO [email protected] Nancy Gadallah, DO (PRINCIPAL_INVESTIGATOR)
NYU Langone Health	Brooklyn	New York	11220	Maria Cotrina-Vidal [email protected] Aaron Lord, MD, MSc [email protected] Aaron Lord, MD, MSc (PRINCIPAL_INVESTIGATOR)
Buffalo General Medical Center	Buffalo	New York	14203	-
North Shore University Hospital	Manhasset	New York	11030	Rohan Arora [email protected] Rohan Arora, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai West	New York	New York	10029	Laura Stein, MD, MPH [email protected] Laura Stein, MD, MPH (PRINCIPAL_INVESTIGATOR)
NYP Columbia University Medical Center	New York	New York	10032	Angela Velazquez [email protected] Shivani Ghoshal, MD [email protected]; Shivani Ghoshal, MD (PRINCIPAL_INVESTIGATOR)
The Mount Sinai Hospital	New York	New York	10029	Laura Stein, MD, MPH [email protected] Laura Stein, MD, MPH (PRINCIPAL_INVESTIGATOR)
SUNY Upstate Medical University	Syracuse	New York	13202	Deb Lena [email protected] Julius-Gene LaTorre, MD, MPH [email protected] Julius-Gene LaTorre, MD, MPH (PRINCIPAL_INVESTIGATOR)
Westchester Medical Center	Valhalla	New York	10595	Gurmeen Kaur, MD [email protected] Gurmeen Kaur, MD (PRINCIPAL_INVESTIGATOR)
Duke University Hospital	Durham	North Carolina	27710	Rosanna Escobar-Spadina [email protected] Alexander Limkakeng, MD, MHSc [email protected] Alexander Limkakeng, MD, MHSc (PRINCIPAL_INVESTIGATOR)
Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	27157	-
University of Cincinnati Medical Center	Cincinnati	Ohio	45267	Yasmin Aziz, MD [email protected] Yasmin Aziz, MD (PRINCIPAL_INVESTIGATOR)
OSU Wexner Medical Center	Columbus	Ohio	43210	Jan Bittar, MD [email protected] Jan Bittar, MD (PRINCIPAL_INVESTIGATOR)
Ascension St. John	Tulsa	Oklahoma	74104	Rahul Rahangdale, MD [email protected] Rahul Rahangdale, MD (PRINCIPAL_INVESTIGATOR)
Providence St. Vincent Medical Center	Portland	Oregon	97225	Kishan Patel, MD [email protected] Kishan Patel, MD (PRINCIPAL_INVESTIGATOR)
Saint Luke's Hospital of Bethlehem Pennsylvania	Bethlehem	Pennsylvania	18015	Daniel Ackerman, MD [email protected] Daniel Ackerman, MD (PRINCIPAL_INVESTIGATOR)
Temple University Hospital	Philadelphia	Pennsylvania	19140	Nina Gentile, MD [email protected] Nina Gentile, MD (PRINCIPAL_INVESTIGATOR)
Rhode Island Hospital	Providence	Rhode Island	02903	Farhan Khan, MD [email protected] Farhan Khan, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina University Hospital	Charleston	South Carolina	32608	Caitlan LeMatty [email protected] Christine Holmstedt, DO [email protected] Christine Holmstedt, DO (PRINCIPAL_INVESTIGATOR)
Prisma Health Greenville Memorial	Greenville	South Carolina	29605	Sanjeev Sivakumar, MD [email protected] Sanjeev Sivakumar, MD (PRINCIPAL_INVESTIGATOR)
Methodist University Hospital	Memphis	Tennessee	38104	Quentin Thacker [email protected] Balaji Krishnaiah, MD [email protected] Balaji Krishnaiah, MD (PRINCIPAL_INVESTIGATOR)
Memorial Hermann Texas Medical Center	Houston	Texas	77030	Prasen Marella [email protected] Andrew Barreto, MD, MS [email protected] Andrew Barreto, MD, MS (PRINCIPAL_INVESTIGATOR)
University of Utah Healthcare	Salt Lake City	Utah	84132	-
UVA Medical Center	Charlottesville	Virginia	22901	Amna Sohail, MBBS, MD [email protected] Amna Sohail, MBBS, MD (PRINCIPAL_INVESTIGATOR)
VCU Medical Center	Richmond	Virginia	23298	-
Harborview Medical Center	Seattle	Washington	98104	David Tirschwell, MD, MSc. [email protected] David Tirschwell, MD, MSc. (PRINCIPAL_INVESTIGATOR)
Ascension Columbia St. Mary's Hospital	Milwaukee	Wisconsin	53211	Lakiesha Coleman [email protected] William Taylor, DO [email protected] William Taylor, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition

Stroke

By specialty

Neurology Brain disorders

By research site

University of Alabama Hospital· Birmingham, AL Banner University Medical Center· Phoenix, AZ Mayo Clinic Phoenix· Phoenix, AZ Banner University Medical Center - Tucson· Tucson, AZ UCSD Health La Jolla· La Jolla, CA Kaiser Permanente Los Angeles· Los Angeles, CA

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