BridgeMD
New treatment option for Ischemic Stroke
Official title Strategy for Improving Stroke Treatment Response
ClinicalTrials.gov ID: NCT05948566
What this study is testing
What is TS23?
TS23 is an investigational medicine, being studied as a potential treatment for ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years and older
- Suspected anterior circulation acute ischemic stroke
- NIH Stroke Scale score ≥4 prior to randomization a. The participant must have a clearly disabling deficit if NIHSS is 4-5.
- Favorable baseline neuroimaging consisting of all of the following:
- ASPECTS of 6 or more on CT (or ASPECTS of ≥7 on MRI)
You likely can't join if
- Received endovascular treatment with clot engagement.
- Patients who undergo groin puncture but clot engagement is not attempted due to spontaneous distal migration are permitted to be enrolled in the...
- Patients who undergo groin puncture but clot is not engaged due to reasons other than spontaneous distal migration are NOT permitted.
- Received or planned to receive intravenous thrombolysis.
- Pre-stroke modified Rankin score \>2.
- Previous treatment with TS23 or known previous allergy to antibody therapy.
See the full eligibility criteria
- Age 18 years and older
- Suspected anterior circulation acute ischemic stroke
- NIH Stroke Scale score ≥4 prior to randomization a. The participant must have a clearly disabling deficit if NIHSS is 4-5.
- Favorable baseline neuroimaging consisting of all of the following:
- ASPECTS of 6 or more on CT (or ASPECTS of ≥7 on MRI)
- Favorable perfusion imaging on CT perfusion (CTP)/MR-perfusion weighted imaging (PWI) consisting of all of the following: i. Mismatch ratio of penumbra: core \>1.2 ii. Mismatch volume \>10 cc iii. Core \ 6s minus...
- Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well.
- Able to receive assigned study drug within 120 minutes of qualifying perfusion imaging. \
- Informed consent for the study participation obtained from participant or their legally authorized representatives.
- Study drug administration is encouraged within 90 minutes after qualifying perfusion image but is allowed up to 120 minutes. After 120 minutes, another perfusion image to ensure that are met is required.
- Received endovascular treatment with clot engagement.
- Patients who undergo groin puncture but clot engagement is not attempted due to spontaneous distal migration are permitted to be enrolled in the trial if all other eligibility criteria are met.
- Patients who undergo groin puncture but clot is not engaged due to reasons other than spontaneous distal migration are NOT permitted.
- Received or planned to receive intravenous thrombolysis.
- Pre-stroke modified Rankin score \>2.
- Previous treatment with TS23 or known previous allergy to antibody therapy.
- Known pregnancy, women who are breastfeeding or plan to breastfeed within 3 months of receiving TS23 or have a positive urine or serum pregnancy test for women of childbearing potential.
- Known previous stroke in the past 90 days.
- Known previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or arterial venous malformation.
- Known active diagnosis of intracranial neoplasm.
- Clinical presentation suggestive of a subarachnoid hemorrhage, even if initial CT scan was normal.
- Surgery or biopsy of parenchymal organ in the past 30 days.
- Known trauma with internal injuries or persistent ulcerative wounds in the past 30 days.
- Severe head trauma in the past 90 days.
- Persistent systolic blood pressure \>180mmHg or diastolic blood pressure \>105mmHg despite best medical management.
- Serious systemic hemorrhage in the past 30 days.
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with International Normalized Ratio (INR) \>1.7.
- Platelets \<100,000/mm3.
- Hematocrit \<25 %.
- Elevated aPTT above laboratory upper limit of normal.
- Creatinine \> 4 mg/dl, or patients receiving renal dialysis, regardless of creatinine.
- Received the following within the previous 24 hours:
- If patient received unfractionated heparin within the last 24 hours, the patient must have an aPTT within normal range prior to enrollment.
- Low molecular weight heparins such as Dalteparin, enoxaparin, tinzaparin in full dose within the previous 24 hours.
- Received Factor Xa inhibitors (such as Fondaparinux, apixaban or rivaroxaban) within the past 48 hours.
- Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours.
- Received glycoprotein IIb/IIIa inhibitors within the past 14 days.
- Known pre-existing neurological or psychiatric disease which would confound the neurological/functional evaluations.
- Current participation in another research drug treatment protocol (i.e., participants could not start another experimental agent until after 90 days).
- Concurrent acute myocardial infarction, pulmonary embolism, deep venous thrombosis or other thrombotic event that requires anticoagulation or anti-platelet treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Newark, Delaware, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Burnsville, Minnesota, United States
- Edina, Minnesota, United States
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Sacramento, California, United States and 42 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.