RECRUITING

Strategy for Improving Stroke Treatment Response

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Strategy for Improving Stroke Treatment Response (SISTER) Trial

Quick Facts

Study Start:2024-03-18

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05948566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 years and older 2. Suspected anterior circulation acute ischemic stroke 3. Presenting NIH Stroke Scale score \>/= 6 4. Favorable baseline neuroimaging 1. CT scan with ASPECTS of \>/=6, or MRI with ASPECTS of \>/=7 and 2. CT or MR Perfusion with a mismatch ratio \>1.2 between the volume of hypoperfusion and the volume of the ischemic core, an absolute difference in volume \> 10 ml, and an ischemic-core volume of less than 70 ml. and 3. Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well 5. Informed consent for the study participation obtained from participant or their legally authorized representatives.	1. Patients planned to receive endovascular treatment. 2. Patients that received or planned to receive intravenous thrombolysis. 3. Pre-stroke modified Rankin score \>2. 4. Known previous allergy to antibody therapy. 5. Known pregnancy or positive urine or serum pregnancy test for women of child bearing potential. 6. Known previous stroke in the past 90 days. 7. Known previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation. 8. Clinical presentation suggestive of a subarachnoid hemorrhage, even if initial CT scan was normal. 9. Surgery or biopsy of parenchymal organ in the past 30 days. 10. Known trauma with internal injuries or ulcerative wounds in the past 30 days. 11. Severe head trauma in the past 90 days. 12. Persistent systolic blood pressure \>180mmHg or diastolic blood pressure \>105mmHg despite best medical management. 13. Serious systemic hemorrhage in the past 30 days. 14. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \>1.7. 15. Platelets \<100,000/mm3. 16. Hematocrit \<25 %. 17. Elevated PTT above laboratory upper limit of normal. 18. Creatinine \> 4 mg/dl, or patients receiving renal dialysis, regardless of creatinine. 19. Received heparin or low molecular weight heparins (such as dalteparin, enoxaparin, tinzaparin) in full dose within the previous 24 hours. 20. Received Factor Xa inhibitors (such as fondaparinux, apixaban or rivaroxaban) within the past 48 hours. 21. Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours. 22. Received glycoprotein IIb/IIIa inhibitors within the past 14 days. 23. Known pre-existing neurological or psychiatric disease which would confound the neurological/functional evaluations. 24. Current participation in another research drug treatment protocol (i.e., participants could not start another experimental agent until after 90 days). 25. Concurrent acute myocardial infarction, pulmonary embolism, deep venous thrombosis or other thrombotic event that requires anticoagulation or anti-platelet treatment.

Inclusion Criteria

Exclusion Criteria

1. Age 18 years and older
2. Suspected anterior circulation acute ischemic stroke
3. Presenting NIH Stroke Scale score \>/= 6
4. Favorable baseline neuroimaging
1. CT scan with ASPECTS of \>/=6, or MRI with ASPECTS of \>/=7 and
2. CT or MR Perfusion with a mismatch ratio \>1.2 between the volume of hypoperfusion and the volume of the ischemic core, an absolute difference in volume \> 10 ml, and an ischemic-core volume of less than 70 ml. and
3. Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well
5. Informed consent for the study participation obtained from participant or their legally authorized representatives.

1. Patients planned to receive endovascular treatment.
2. Patients that received or planned to receive intravenous thrombolysis.
3. Pre-stroke modified Rankin score \>2.
4. Known previous allergy to antibody therapy.
5. Known pregnancy or positive urine or serum pregnancy test for women of child bearing potential.
6. Known previous stroke in the past 90 days.
7. Known previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation.
8. Clinical presentation suggestive of a subarachnoid hemorrhage, even if initial CT scan was normal.
9. Surgery or biopsy of parenchymal organ in the past 30 days.
10. Known trauma with internal injuries or ulcerative wounds in the past 30 days.
11. Severe head trauma in the past 90 days.
12. Persistent systolic blood pressure \>180mmHg or diastolic blood pressure \>105mmHg despite best medical management.
13. Serious systemic hemorrhage in the past 30 days.
14. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \>1.7.
15. Platelets \<100,000/mm3.
16. Hematocrit \<25 %.
17. Elevated PTT above laboratory upper limit of normal.
18. Creatinine \> 4 mg/dl, or patients receiving renal dialysis, regardless of creatinine.
19. Received heparin or low molecular weight heparins (such as dalteparin, enoxaparin, tinzaparin) in full dose within the previous 24 hours.
20. Received Factor Xa inhibitors (such as fondaparinux, apixaban or rivaroxaban) within the past 48 hours.
21. Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours.
22. Received glycoprotein IIb/IIIa inhibitors within the past 14 days.
23. Known pre-existing neurological or psychiatric disease which would confound the neurological/functional evaluations.
24. Current participation in another research drug treatment protocol (i.e., participants could not start another experimental agent until after 90 days).
25. Concurrent acute myocardial infarction, pulmonary embolism, deep venous thrombosis or other thrombotic event that requires anticoagulation or anti-platelet treatment.

Contacts and Locations

Study Contact

Rebeca Aragon Garcia, BS, CCRC

CONTACT

9736688644

aragonra@ucmail.uc.edu

Pam Plummer, MSN,RN, CCRC

CONTACT

5138852437

plummepa@ucmail.uc.edu

Principal Investigator

Eva Mistry, MBBS

PRINCIPAL_INVESTIGATOR

University of Cincinnati

Study Locations (Sites)

University of Alabama Hospital

Birmingham, Alabama, 35233

United States

Banner University Medical Center

Phoenix, Arizona, 85006

United States

Mayo Clinic Phoenix

Phoenix, Arizona, 85054

United States

UCSD Health La Jolla

La Jolla, California, 92093

United States

Kaiser Permanente Los Angeles

Los Angeles, California, 90027

United States

Sutter Medical Center

Sacramento, California, 95816

United States

UCSD Medical Center- Hillcrest Hospital

San Diego, California, 92103

United States

Hartford Hospital

Hartford, Connecticut, 06102

United States

Yale New Haven Hospital

New Haven, Connecticut, 06511

United States

Christiana Hospital

Newark, Delaware, 19718

United States

UF Health Shands Hospital

Gainesville, Florida, 32608

United States

Jackson Memorial Hospital

Miami, Florida, 33136

United States

Grady Memorial Hospital

Atlanta, Georgia, 30303

United States

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242

United States

Baptist Healthcare System, Inc.

Lexington, Kentucky, 40503

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Massachusetts General Hospital

Boston, Massachusetts, 02171

United States

M Health Fairview Ridges Hospital

Burnsville, Minnesota, 55337

United States

M Health Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, 55455

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Barnes Jewish Hospital

Saint Louis, Missouri, 63110

United States

JFK Medical Center

Edison, New Jersey, 08837

United States

NYU Langone Health

Brooklyn, New York, 11220

United States

Buffalo General Medical Center

Buffalo, New York, 14203

United States

North Shore University Hospital

Manhasset, New York, 11030

United States

Mount Sinai West

New York, New York, 10029

United States

The Mount Sinai Hospital

New York, New York, 10029

United States

NYP Columbia University Medical Center

New York, New York, 10032

United States

SUNY Upstate Medical University

Syracuse, New York, 13202

United States

Duke University Hospital

Durham, North Carolina, 27710

United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267

United States

OSU Wexner Medical Center

Columbus, Ohio, 43210

United States

Ascension St. John

Tulsa, Oklahoma, 74104

United States

Saint Luke's Hospital of Bethlehem Pennsylvania

Bethlehem, Pennsylvania, 18015

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

Medical University of South Carolina University Hospital

Charleston, South Carolina, 32608

United States

Prisma Health Greenville Memorial

Greenville, South Carolina, 29605

United States

Methodist University Hospital

Memphis, Tennessee, 38104

United States

Memorial Hermann Texas Medical Center

Houston, Texas, 77030

United States

University of Utah Healthcare

Salt Lake City, Utah, 84132

United States

UVA Medical Center

Charlottesville, Virginia, 22901

United States

Harborview Medical Center

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: Translational Sciences, Inc.

Eva Mistry, MBBS, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-18

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-03-18

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Ischemic Stroke