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Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT (EXTEND-IV)

Primary Purpose

Ischemic Stroke, Acute

Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Intravenous tenecteplase
Placebo
Sponsored by
Hospital Moinhos de Vento
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke, Acute focused on measuring Ischemic Stroke, Thrombolysis, Tenecteplase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment with Alteplase due to onset >4.5 hours and is ineligible for endovascular treatment under standard of care due to absence of proximal arterial occlusion (e.g. intracranial ICA, MCA-M1 and dominant M2 segments, and vertebrobasilar arteries).

    • Dominant M2 segment is defined is a division supplying >50% of the MCA territory vs co-dominant supplying 50% of the MCA territory vs non-dominant supplying <50% of the MCA territory.

      2. No significant pre-stroke functional disability (mRS ≤2). 3. Evidence of a disabling deficit including significant aphasia, neglect, hemianopsia, or hemiparesis and/or baseline NIHSS score ≥4 points (obtained prior to randomization).

      4. Age ≥18 years (no upper age limit). 5. The presence of a Target Mismatch defined as:

      a. Ischemic Core < 50cc) (defined on NCCT/CTP* or DWI-MRI)

    • e-volume NCCT can be used to exclude patients if the investigator believes that its volume assessment is more reliable than the CTP volume in any particular case.

      b. Mismatch Volume (TMax >6sec lesion - Core volume lesion) >10cc c. Mismatch Ratio >1.4 6. Patient treatable within 4.5-12 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as initiation of IV TNK or placebo infusion.

      7. Informed consent obtained from patient or acceptable patient surrogate.

Exclusion Criteria:

  1. Intracranial hemorrhage (ICH) identified by CT or MRI.
  2. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of < 4 at randomization.
  3. Pre-stroke mRS score of ≥ 2 (indicating previous disability)
  4. Contra indication to imaging with MR or CT with contrast agents.
  5. Infarct core >1/3 MCA territory qualitatively or >50 mL quantitatively (determined by DWI lesion on MR).
  6. Participation in any investigational study in the previous 30 days
  7. Any terminal illness such that patient would not be expected to survive more than 1 year).
  8. Baseline platelet count < 100.000/µL
  9. Woman of childbearing potential who is known to be pregnant or who has a positive pregnancy test on admission.
  10. Previous stroke within last three months.
  11. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma.
  12. Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.6).
  13. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged partial thromboplastin time exceeding the upper limit of the local laboratory normal range
  14. Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors (clopidogrel or low-dose aspirin) prior to study entry is permitted.
  15. Clinically significant hypoglycemia.
  16. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of "aggressive treatment" is left to the discretion of the responsible Investigator.
  17. Hereditary or acquired hemorrhagic diathesis.
  18. Gastrointestinal or urinary bleeding within the preceding 21 days.
  19. Major surgery within the preceding 14 days which poses risk in the opinion of the Investigator.
  20. Exposure to a thrombolytic agent within the previous 72 hours.
  21. Subject participating in a study involving an investigational drug or device that would impact this study.

Sites / Locations

  • Hospital Moinhos de VentoRecruiting
  • Hospital das Clínicas BotucatuRecruiting
  • Hospital das Clínicas - UNICAMPRecruiting
  • Hospital das Clínicas UFPRRecruiting
  • Hospital Geral de FortalezaRecruiting
  • Hospital Metropolitano de MaceióRecruiting
  • Hospital de Clínicas de Porto Alegre
  • Hospital de Clínicas de Porto AlegreRecruiting
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São PauloRecruiting
  • Hospital Getúlio Vargas Sapucaia do SulRecruiting
  • Hospital de Base São José do Rio PretoRecruiting
  • Hospital São Paulo
  • Hospital TramandaíRecruiting
  • Hospital Estadual CentralRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Intravenous tenecteplase (TNK)

Arm Description

Placebo administered as a single bolus injection over 5 seconds

Intravenous thrombolysis with Tenecteplase (TNK) at a dose of 0.25 mg/Kg (maximum 25mg, administered as a bolus over 5 seconds)

Outcomes

Primary Outcome Measures

Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days
Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days as following: If NIHSS <10 and Baseline mRS 0 or 1: 90-day mRS ≤1 If NIHSS <10 and Baseline mRS 2: 90-day mRS ≤2 If NIHSS ≥10 and Baseline mRS 0 or 1: 90-day mRS ≤2 If NIHSS ≥10 and Baseline mRS 2: 90-day mRS ≤3

Secondary Outcome Measures

Rates of Excellent Outcome defined as mRS ≤ 1 and/ or equal to Baseline mRS at 90 days
Rates of Excellent Outcome defined as mRS ≤ 1 and/ or equal to Baseline mRS at 90 days
Rates of Independent Outcome defined as mRS ≤ 2 and/ or equal to Baseline mRS at 90 days
Rates of Independent Outcome defined as mRS ≤ 2 and/ or equal to Baseline mRS at 90 days
Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS) at 90 days
Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS) at 90 days
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 3-5 days (if available)
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 3-5 days (if available)
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 24 hours (-2/+12 hours)
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 24 hours (-2/+12 hours)
Dramatic early favorable response as determined by an NIHSS of 0-2 or NIHSS improvement ≥ 4 points at 24 (-2/+12 hours) hours
Dramatic early favorable response as determined by an NIHSS of 0-2 or NIHSS improvement ≥ 4 points at 24 (-2/+12 hours) hours
Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and one year, between interventional therapy vs medical therapy alone
Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and one year, between interventional therapy vs medical therapy alone
Brain tissue reperfusion evaluated by CT or MRI perfusion at 24 hours in both treatment groups (if available)
Brain tissue reperfusion evaluated by CT or MRI perfusion at 24 hours in both treatment groups (if available)
Mortality at 90 days ( safety outcome)
Mortality at 90 days ( safety outcome)
Clinically significant ICH rates at 24 (-2/+12) hours.
Clinically significant ICH rates at 24 (-2/+12) hours. All intracerebral hemorrhages will be classified by a central core-lab using the ECASS criteria. Symptomatic ICH will be defined as per the modified SITS-MOST definition: local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage on the post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 h, or leading to death that the CEC/DSMB judges is causative of the deterioration.
Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 24 (-2/+12)
Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 24 (-2/+12) hours
Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors at the central core lab) who are blinded to treatment.
Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors at the central core lab) who are blinded to treatment. Primary Endpoint will consider central core lab readings only (video interview with RFA method) with local reading as a back-up mechanism

Full Information

First Posted
December 13, 2021
Last Updated
May 24, 2023
Sponsor
Hospital Moinhos de Vento
Collaborators
Ministry of Health, Brazil, Boehringer Ingelheim, Brainomix Limited, iSchemaView, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05199662
Brief Title
Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT
Acronym
EXTEND-IV
Official Title
A Phase III, Randomized, Multi-center Clinical Trial That Will Examine Whether Treatment With Intravenous TNK is Superior to Placebo in Patients Who Suffer a Non-large Vessel Occlusion Ischemic Stroke Within 4.5-12 Hours From Time Last Seen Well
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Moinhos de Vento
Collaborators
Ministry of Health, Brazil, Boehringer Ingelheim, Brainomix Limited, iSchemaView, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase III, randomized, multi-center clinical trial that will examine whether treatment with intravenous TNK is superior to placebo in patients who suffer a non-large vessel occlusion ischemic stroke within 4.5-12 hours from time last seen well. The randomization employs a 1:1 ratio of intravenous thrombolysis with Tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from time last seen well (TLSW) and with a clinical-radiological mismatch or evidence of salvageable brain tissue on perfusion imaging.
Detailed Description
Prospective, multi-center, randomized, controlled, double blinded trial with an adaptive design and population enrichment. The randomization employs a 1:1 ratio of intravenous thrombolysis with Tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from time last seen well (TLSW) and with a clinical-radiological mismatch or evidence of salvageable brain tissue on perfusion imaging. Randomization will be done under a minimization process using age (≤70 vs. >70 years), baseline NIHSS (≤10 vs. >10), therapeutic window (4.5-9 or 9-12 hours after TLKW), randomization scenario and clinical site. For the primary endpoint, subjects will be followed for 90 days post-randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Acute
Keywords
Ischemic Stroke, Thrombolysis, Tenecteplase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
642 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo administered as a single bolus injection over 5 seconds
Arm Title
Intravenous tenecteplase (TNK)
Arm Type
Experimental
Arm Description
Intravenous thrombolysis with Tenecteplase (TNK) at a dose of 0.25 mg/Kg (maximum 25mg, administered as a bolus over 5 seconds)
Intervention Type
Drug
Intervention Name(s)
Intravenous tenecteplase
Other Intervention Name(s)
TNK, Metalyse
Intervention Description
Intravenous tenecteplase (TNK). Patients will receive intravenous TNK (0.25mg/kg, maximum 25mg, administered as a bolus over 5 seconds).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching IV TNK
Primary Outcome Measure Information:
Title
Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days
Description
Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days as following: If NIHSS <10 and Baseline mRS 0 or 1: 90-day mRS ≤1 If NIHSS <10 and Baseline mRS 2: 90-day mRS ≤2 If NIHSS ≥10 and Baseline mRS 0 or 1: 90-day mRS ≤2 If NIHSS ≥10 and Baseline mRS 2: 90-day mRS ≤3
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Rates of Excellent Outcome defined as mRS ≤ 1 and/ or equal to Baseline mRS at 90 days
Description
Rates of Excellent Outcome defined as mRS ≤ 1 and/ or equal to Baseline mRS at 90 days
Time Frame
90 days
Title
Rates of Independent Outcome defined as mRS ≤ 2 and/ or equal to Baseline mRS at 90 days
Description
Rates of Independent Outcome defined as mRS ≤ 2 and/ or equal to Baseline mRS at 90 days
Time Frame
90 days
Title
Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS) at 90 days
Description
Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS) at 90 days
Time Frame
90 days
Title
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 3-5 days (if available)
Description
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 3-5 days (if available)
Time Frame
3-5 days
Title
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 24 hours (-2/+12 hours)
Description
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 24 hours (-2/+12 hours)
Time Frame
24 hours (-2/+12 hours)
Title
Dramatic early favorable response as determined by an NIHSS of 0-2 or NIHSS improvement ≥ 4 points at 24 (-2/+12 hours) hours
Description
Dramatic early favorable response as determined by an NIHSS of 0-2 or NIHSS improvement ≥ 4 points at 24 (-2/+12 hours) hours
Time Frame
24 (-2/+12 hours) hours
Title
Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and one year, between interventional therapy vs medical therapy alone
Description
Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and one year, between interventional therapy vs medical therapy alone
Time Frame
3 month, 6 months and one year
Title
Brain tissue reperfusion evaluated by CT or MRI perfusion at 24 hours in both treatment groups (if available)
Description
Brain tissue reperfusion evaluated by CT or MRI perfusion at 24 hours in both treatment groups (if available)
Time Frame
24 hours
Title
Mortality at 90 days ( safety outcome)
Description
Mortality at 90 days ( safety outcome)
Time Frame
90 days
Title
Clinically significant ICH rates at 24 (-2/+12) hours.
Description
Clinically significant ICH rates at 24 (-2/+12) hours. All intracerebral hemorrhages will be classified by a central core-lab using the ECASS criteria. Symptomatic ICH will be defined as per the modified SITS-MOST definition: local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage on the post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 h, or leading to death that the CEC/DSMB judges is causative of the deterioration.
Time Frame
24 (-2/+12) hours
Title
Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 24 (-2/+12)
Description
Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 24 (-2/+12) hours
Time Frame
24 (-2/+12)
Title
Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors at the central core lab) who are blinded to treatment.
Description
Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors at the central core lab) who are blinded to treatment. Primary Endpoint will consider central core lab readings only (video interview with RFA method) with local reading as a back-up mechanism
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Cost effectiveness analysis of IV TNK vs standard medical therapy
Description
Cost effectiveness analysis of IV TNK vs standard medical therapy
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment with Alteplase due to onset >4.5 hours and is ineligible for endovascular treatment under standard of care due to absence of proximal arterial occlusion (e.g. intracranial ICA, MCA-M1 and dominant M2 segments, and vertebrobasilar arteries). * Dominant M2 segment is defined is a division supplying >50% of the MCA territory vs co-dominant supplying 50% of the MCA territory vs non-dominant supplying <50% of the MCA territory. No significant pre-stroke functional disability (mRS ≤2). Age ≥18 years (no upper age limit). Clinical or imaging mismatch evidence in distal artery territories, defined as one of the following scenarios (A, B or C): Scenario A - all of the following: Significant cortical neurological deficit (moderate to severe afasia, moderate to severe heminegligence, severe hemianopsia) with the addition or not of motor symptoms OR any motor deficit accompanied of cortical symptoms of any severity; Contrast-enhanced CT of the head or head MRI with <50% involvement of the vascular territory corresponding to the clinical manifestation; Arterial head angiotomography or arterial head angioMRI WITHOUT proximal intracranial artery occlusion that would require endovascular therapy (for example, ICA intracranial, MCA-M1 and M2 dominant segments and vertebral and basilar arteries) Scenario B - all of the following: NIHSS score ≥ 4 due to any neurologic deficits; Non-contrast CT of the head or head MRI com <50% involvement of the vascular territory corresponding to the clinical manifestation; Arterial head angioCT or arterial head MRI WITHOUT proximal intracranial artery occlusion that would require endovascular therapy (for example, ICA intracranial, MCA-M1 and M2 dominant segments and vertebral and basilar arteries) Arterial head angioCT with distal occlusion on MIP or wedge-shaped lesion on parenchymography on the source-image of angiotomography OR CT perfusion with wedge-shaped cortical lesion. Scenario C - all of the following: NIHSS score ≥ 4 due to any neurologic deficits; The presence of a Target Mismatch defined as: Ischemic Core <50cc (defined on NCCT/CTP* or DWI MRI) *Volume NCCT can be used to exclude patients if the investigator believes that its volume assessment is more reliable that the CTP in any particular case. Mismatch Volume (Tmax >6sec lesion - Core volume lesion) >10cc Mismatch Ratio >1.4 Patient treatable within 4.5-12 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as initiation of IV TNK or placebo infusion. Informed consent obtained from patient or acceptable patient surrogate. Exclusion Criteria: Intracranial hemorrhage (ICH) identified by CT or MRI. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient without eligibility criteria. Pre-stroke mRS score of ≥ 2 (indicating previous disability) Contra indication to imaging with MR or CT with contrast agents. Infarct core >1/3 MCA territory qualitatively or >50 mL quantitatively (determined by DWI lesion on MR). Participation in any investigational study in the previous 30 days Any terminal illness such that patient would not be expected to survive more than 1 year). Baseline platelet count < 100.000/µL Woman of childbearing potential who is known to be pregnant or who has a positive pregnancy test on admission. Previous stroke within last three months. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma. Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.6). Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged partial thromboplastin time exceeding the upper limit of the local laboratory normal range Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors (clopidogrel or low-dose aspirin) prior to study entry is permitted. Clinically significant hypoglycemia. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of "aggressive treatment" is left to the discretion of the responsible Investigator. Hereditary or acquired hemorrhagic diathesis. Gastrointestinal or urinary bleeding within the preceding 21 days. Major surgery within the preceding 14 days which poses risk in the opinion of the Investigator. Exposure to a thrombolytic agent within the previous 72 hours. Subject participating in a study involving an investigational drug or device that would impact this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gisele Sampaio Silva, MD, MPH, PhD
Phone
5511983580583
Email
giselesampaio@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo Carbonera, MD, MsC
Phone
555135378195
Email
leonardo.carbonera@hmv.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisele Sampaio Silva, MD, MPH, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raul G Nogueira, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheila CO Martins, MD, PhD
Organizational Affiliation
Hospital Moinhos de Vento
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila Martins
Facility Name
Hospital das Clínicas Botucatu
City
Botucatu
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Bazan, MD
Facility Name
Hospital das Clínicas - UNICAMP
City
Campinas
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wagner Avelar, MD
Facility Name
Hospital das Clínicas UFPR
City
Curitiba
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viviane Zetola, MD
Facility Name
Hospital Geral de Fortaleza
City
Fortaleza
ZIP/Postal Code
60175-295
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabricio Lima, MD, PhD
Facility Name
Hospital Metropolitano de Maceió
City
Maceió
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebeca Teixeira, MD
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-007
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Almeida
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Almeida, MD
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
City
Ribeirão Preto
ZIP/Postal Code
14015-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Octavio Marques Pontes-Neto, MD, PhD
Facility Name
Hospital Getúlio Vargas Sapucaia do Sul
City
Sapucaia do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diógenes Zan, MD
Facility Name
Hospital de Base São José do Rio Preto
City
São José Do Rio Preto
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Battaglini, MD
Facility Name
Hospital São Paulo
City
São Paulo
ZIP/Postal Code
04037-002
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gisele Sampaio Silva, MD, PhD
First Name & Middle Initial & Last Name & Degree
Maramelia Miranda Alves, MD, MsC
Facility Name
Hospital Tramandaí
City
Tramandaí
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tércio Tedesco JR, MD
Facility Name
Hospital Estadual Central
City
Vitória
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Fiorot JR, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT

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