脳卒中治療の反応を改善するための戦略 (SISTER)
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.
調査の概要
詳細な説明
SISTER is a Phase II, Bayesian, adaptive, randomized, dose-finding trial of TS23 in patients with acute ischemic stroke. Patients with an anterior cerebral circulation acute ischemic stroke and present between 4.5 to 24 hours of their last known well with a presenting NIH Stroke Scale Score >/=4 (with the patient having a clearly disabling deficit if the NIHSS is 4 or 5) and an imaging evidence of salvageable brain tissue will be eligible and will be approached for an informed consent for study participation. Patients with an NIHSS of 4-5 must have a new, disabling neuro-logic deficit to be eligible for the study. After informed consent is provided, the study will randomize to 4 doses of TS23 and placebo. The trial will enroll up to 150 subjects at up to 70 participating US sites.
The effects of TS23 will be evaluated on two following primary outcomes using a utility function: 1) primary safety outcome: any intracerebral hemorrhage at 30 (+/-4) hours and 2) primary efficacy outcome: NIH Stroke Scale score at 30 (+/-4) hours after drug administration. The study will follow participants for 90 (+/-7) days.
Primary Objective: To identify a dose of TS23 that is safe and more efficacious than placebo for the treatment of patients from 4.5 to 24 hours of last known well, who have evidence of core-penumbra mismatch on perfusion imaging and are not a candidate for standard of care reperfusion therapies.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Pam Plummer, MSN,RN, CCRC
- 電話番号:5138852437
- メール:plummepa@ucmail.uc.edu
研究連絡先のバックアップ
- 名前:Rebeca Aragon Garcia, BS, CCRC
- 電話番号:9736688644
- メール:aragonra@ucmail.uc.edu
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35233
- 募集
- University of Alabama Hospital
-
コンタクト:
- Felix Guerra Castanon, MD
- メール:fguerracastanon@uabmc.edu
-
主任研究者:
- Felix Guerra Castanon, MD
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85006
- 募集
- Banner University Medical Center
-
主任研究者:
- Savdeep Singh, MD
-
コンタクト:
- Savdeep Singh, MD
- メール:savdeepsingh@arizona.edu
-
Phoenix、Arizona、アメリカ、85054
- 引きこもった
- Mayo Clinic Phoenix
-
Tucson、Arizona、アメリカ、85719
- 募集
- Banner University Medical Center - Tucson
-
コンタクト:
- Firas Kaddouh, MD, MHS
- メール:firaskaddouh@arizona.edu
-
主任研究者:
- Firas Kaddouh, MD, MHS
-
-
California
-
La Jolla、California、アメリカ、92093
- 募集
- UCSD Health La Jolla
-
コンタクト:
- Maryo Jajo
- メール:mjajo@health.ucsd.edu
-
主任研究者:
- Royya Modir, MD
-
コンタクト:
- Royya Modir, MD
- メール:rmodir@ucsd.edu
-
Los Angeles、California、アメリカ、90027
- 募集
- Kaiser Permanente Los Angeles
-
コンタクト:
- Navdeep Sangha, MD
- メール:navdeep.x.sangha@kp.org
-
主任研究者:
- Navdeep Sangha, MD
-
Sacramento、California、アメリカ、95816
- 引きこもった
- Sutter Medical Center
-
San Diego、California、アメリカ、92103
- 募集
- UCSD Medical Center- Hillcrest Hospital
-
コンタクト:
- Maryo Jajo
- メール:mjajo@health.ucsd.edu
-
主任研究者:
- Royya Modir, MD
-
コンタクト:
- Royya' Modir, MD
- メール:rmodir@ucsd.edu
-
-
Connecticut
-
Hartford、Connecticut、アメリカ、06102
- 募集
- Hartford Hospital
-
主任研究者:
- Ajay Tunguturi, MD
-
コンタクト:
- Ajay Tunguturi, MD
- メール:ajay.tunguturi@hhchealth.org
-
New Haven、Connecticut、アメリカ、06511
- 募集
- Yale New Haven Hospital
-
コンタクト:
- James Giles, MD, PhD
- メール:james.giles@yale.edu
-
主任研究者:
- James Giles, MD, PhD
-
-
Delaware
-
Newark、Delaware、アメリカ、19718
- 引きこもった
- Christiana Hospital
-
-
Florida
-
Gainesville、Florida、アメリカ、32608
- 終了しました
- UF Health Shands Hospital
-
Miami、Florida、アメリカ、33136
- 募集
- Jackson Memorial Hospital
-
コンタクト:
- Andrea Escobar
- メール:a.escobar1@med.miami.edu
-
コンタクト:
- Gillian Gordon Perue, MD, MBBS, DM
- メール:ggordonperue@miami.edu
-
主任研究者:
- Gillian Gordon Perue, MD, MBBS, DM
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30303
- 募集
- Grady Memorial Hospital
-
コンタクト:
- Nicolas Bianchi, MD
- メール:nicolas.a.bianchi@emory.edu
-
主任研究者:
- Nicolas Bianchi, MD
-
-
Illinois
-
Chicago、Illinois、アメリカ、60637
- 積極的、募集していない
- University of Chicago Medical Center
-
-
Iowa
-
Iowa City、Iowa、アメリカ、52242
- 引きこもった
- University of Iowa Hospitals & Clinics
-
-
Kentucky
-
Lexington、Kentucky、アメリカ、40503
- 募集
- Baptist Healthcare System, Inc.
-
コンタクト:
- Franklin Echevarria
- メール:Franklin.echevarriagonzalez@bhsi.com
-
主任研究者:
- Murali Kolikonda, MD
-
コンタクト:
- Murali Kolikonda, MD
- メール:murali.kolikonda@bhsi.com
-
Louisville、Kentucky、アメリカ、40202
- 募集
- University of Louisville Hospital
-
主任研究者:
- Isaac Abecassis, MD
-
コンタクト:
- Isaac Abecassis, MD
- メール:Isaac.Abecassis@uoflhealth.org
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02115
- 募集
- Brigham and Women's Hospital
-
主任研究者:
- Rahul Mahajan, MD, PhD
-
コンタクト:
- Rahul Mahajan, MD, PhD
- メール:rmahajan@bwh.harvard.edu
-
Boston、Massachusetts、アメリカ、02171
- 募集
- Massachusetts General Hospital
-
主任研究者:
- Aneesh Singhal, MD, MBBS
-
コンタクト:
- Aneesh Singhal, MD, MBBS
- メール:ASINGHAL@mgh.harvard.edu
-
-
Minnesota
-
Burnsville、Minnesota、アメリカ、55337
- 募集
- M Health Fairview Ridges Hospital
-
コンタクト:
- Jessica Staloch
- メール:staloch@umn.edu
-
コンタクト:
- Muhammad Affan, MD, MBBS
- メール:affan004@umn.edu
-
主任研究者:
- Muhammad Affan, MD, MBBS
-
Edina、Minnesota、アメリカ、55435
- 募集
- M Health Fairview Southdale Hospital
-
コンタクト:
- Jessica Staloch
- メール:staloch@umn.edu
-
主任研究者:
- Muhammad Affan, MD, MBBS
-
コンタクト:
- Muhammad Affan, MD,MBBS
- メール:affan004@umn.edu
-
Minneapolis、Minnesota、アメリカ、55455
- 募集
- M Health Fairview University of Minnesota Medical Center
-
コンタクト:
- Jessica Staloch
- メール:staloch@umn.edu
-
コンタクト:
- Muhammad Affan, MD,MBBS
- メール:affan004@umn.edu
-
主任研究者:
- Muhammad Affan, MD,MBBS
-
Saint Paul、Minnesota、アメリカ、55102
- 引きこもった
- United Hospital
-
-
Missouri
-
St Louis、Missouri、アメリカ、63110
- 募集
- Barnes Jewish Hospital
-
主任研究者:
- Charles Kircher, MD
-
コンタクト:
- Charles Kircher, MD
- メール:charles.kircher@wustl.edu
-
-
New Jersey
-
Edison、New Jersey、アメリカ、08837
- 募集
- JFK Medical Center
-
主任研究者:
- Nancy Gadallah, DO
-
コンタクト:
- Nancy Gadallah, DO
- メール:nancy.gadallah@hmhn.org
-
-
New York
-
Brooklyn、New York、アメリカ、11220
- 募集
- NYU Langone Health
-
コンタクト:
- Maria Cotrina-Vidal
- メール:maria.cotrina@nyulangone.org
-
主任研究者:
- Aaron Lord, MD, MSc
-
コンタクト:
- Aaron Lord, MD, MSc
- メール:aaron.lord@nyulangone.org
-
Buffalo、New York、アメリカ、14203
- 引きこもった
- Buffalo General Medical Center
-
Manhasset、New York、アメリカ、11030
- 募集
- North Shore University Hospital
-
主任研究者:
- Rohan Arora, MD
-
コンタクト:
- Rohan Arora
- メール:neuroscienceresearch@northwell.edu
-
New York、New York、アメリカ、10029
- 募集
- The Mount Sinai Hospital
-
コンタクト:
- Laura Stein, MD, MPH
- メール:laura.stein@mountsinai.org
-
主任研究者:
- Laura Stein, MD, MPH
-
New York、New York、アメリカ、10032
- 募集
- NYP Columbia University Medical Center
-
主任研究者:
- Shivani Ghoshal, MD
-
コンタクト:
- Angela Velazquez
- メール:Agv2113@cumc.columbia.edu
-
コンタクト:
- Shivani Ghoshal, MD
- メール:sg3450@cumc.columbia.edu;
-
New York、New York、アメリカ、10029
- 引きこもった
- Mount Sinai West
-
Syracuse、New York、アメリカ、13202
- 募集
- SUNY Upstate Medical University
-
コンタクト:
- Deb Lena
- メール:debl@upstate.edu
-
主任研究者:
- Julius-Gene LaTorre, MD, MPH
-
コンタクト:
- Julius-Gene LaTorre, MD, MPH
- メール:latorrej@upstate.edu
-
Valhalla、New York、アメリカ、10595
- 引きこもった
- Westchester Medical Center
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27710
- 募集
- Duke University Hospital
-
コンタクト:
- Rosanna Escobar-Spadina
- メール:rosanna.escobar@duke.edu
-
主任研究者:
- Alexander Limkakeng, MD, MHSc
-
コンタクト:
- Alexander Limkakeng, MD, MHSc
- メール:alexander.limkakeng@duke.edu
-
Winston-Salem、North Carolina、アメリカ、27157
- 終了しました
- Wake Forest Baptist Medical Center
-
-
Ohio
-
Cincinnati、Ohio、アメリカ、45267
- 募集
- University of Cincinnati Medical Center
-
主任研究者:
- Yasmin Aziz, MD
-
コンタクト:
- Yasmin Aziz, MD
- メール:azizyn@ucmail.uc.edu
-
Columbus、Ohio、アメリカ、43210
- 募集
- OSU Wexner Medical Center
-
主任研究者:
- Jan Bittar, MD
-
コンタクト:
- Jan Bittar, MD
- メール:jan.bittar@osumc.edu
-
-
Oklahoma
-
Tulsa、Oklahoma、アメリカ、74104
- 募集
- Ascension St. John
-
主任研究者:
- Rahul Rahangdale, MD
-
コンタクト:
- Rahul Rahangdale, MD
- メール:rahul.rahangdale@ascension.org
-
-
Oregon
-
Portland、Oregon、アメリカ、97225
- 募集
- Providence St. Vincent Medical Center
-
主任研究者:
- Kishan Patel, MD
-
コンタクト:
- Kishan Patel, MD
- メール:kishan.patel@providence.org
-
-
Pennsylvania
-
Bethlehem、Pennsylvania、アメリカ、18015
- 募集
- Saint Luke's Hospital of Bethlehem Pennsylvania
-
主任研究者:
- Daniel Ackerman, MD
-
コンタクト:
- Daniel Ackerman, MD
- メール:Daniel.Ackerman@sluhn.org
-
Philadelphia、Pennsylvania、アメリカ、19140
- 募集
- Temple University Hospital
-
コンタクト:
- Nina Gentile, MD
- メール:ngentile@temple.edu
-
主任研究者:
- Nina Gentile, MD
-
-
Rhode Island
-
Providence、Rhode Island、アメリカ、02903
- 募集
- Rhode Island Hospital
-
主任研究者:
- Farhan Khan, MD
-
コンタクト:
- Farhan Khan, MD
- メール:fkhan@brownhealth.org
-
-
South Carolina
-
Charleston、South Carolina、アメリカ、32608
- 募集
- Medical University of South Carolina University Hospital
-
コンタクト:
- Caitlan LeMatty
- メール:lemattyc@musc.edu
-
コンタクト:
- Christine Holmstedt, DO
- メール:holmsted@musc.edu
-
主任研究者:
- Christine Holmstedt, DO
-
Greenville、South Carolina、アメリカ、29605
- 募集
- Prisma Health Greenville Memorial
-
コンタクト:
- Sanjeev Sivakumar, MD
- メール:Sanjeev.Sivakumar@prismahealth.org
-
主任研究者:
- Sanjeev Sivakumar, MD
-
-
Tennessee
-
Memphis、Tennessee、アメリカ、38104
- 募集
- Methodist University Hospital
-
コンタクト:
- Quentin Thacker
- メール:qthacker@uthsc.edu
-
主任研究者:
- Balaji Krishnaiah, MD
-
コンタクト:
- Balaji Krishnaiah, MD
- メール:bkrishn4@uthsc.edu
-
-
Texas
-
Houston、Texas、アメリカ、77030
- 募集
- Memorial Hermann Texas Medical Center
-
コンタクト:
- Andrew Barreto, MD, MS
- メール:andrew.d.barreto@uth.tmc.edu
-
コンタクト:
- Prasen Marella
- メール:prasen.r.marella@uth.tmc.edu
-
主任研究者:
- Andrew Barreto, MD, MS
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84132
- 引きこもった
- University of Utah Healthcare
-
-
Virginia
-
Charlottesville、Virginia、アメリカ、22901
- 募集
- UVA Medical Center
-
主任研究者:
- Amna Sohail, MBBS, MD
-
コンタクト:
- Amna Sohail, MBBS, MD
- メール:ZRX5FU@uvahealth.org
-
Richmond、Virginia、アメリカ、23298
- 引きこもった
- VCU Medical Center
-
-
Washington
-
Seattle、Washington、アメリカ、98104
- 引きこもった
- Harborview Medical Center
-
-
Wisconsin
-
Milwaukee、Wisconsin、アメリカ、53211
- 募集
- Ascension Columbia St. Mary's Hospital
-
コンタクト:
- Lakiesha Coleman
- メール:lakiesha.coleman@ascension.org
-
コンタクト:
- William Taylor, DO
- メール:william.taylor3@ascension.org
-
主任研究者:
- William Taylor, DO
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion 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 <70 cc
c. If CT hypodensity is present, then in the investigator's visual assessment, the total acute infarct volume combined area of (a) the CT hypodensity and (b) the perfusion-based core volume (CBF<30%) should be smaller than perfusion-based volume (area of Tmax>6s minus CBF<30%).
-
Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well.
-
Anticipate being 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.
Exclusion Criteria:
-
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター:Placebo
Placebo |
Monoclonal antibody |
|
実験的:Dose 1 TS23
low dose |
Monoclonal antibody |
|
実験的:Dose 2 TS23
next higher dose |
Monoclonal antibody |
|
実験的:Dose 3 TS23
next higher dose |
Monoclonal antibody |
|
実験的:Dose 4 TS23
highest dose |
Monoclonal antibody |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The proportion of patients with ANY intracerebral hemorrhage (ICH)
時間枠:At 30 (+/- 4) hours after study drug
|
Any ICH visualized on the follow-up CT scan |
At 30 (+/- 4) hours after study drug
|
|
Stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS)
時間枠:At 30 (+/- 4) hours after study drug
|
NIHSS is a stroke severity score that ranges from 0 to 42, with higher numbers indicating a more severe stroke. The NIHSS will be adjusted for the baseline value in analysis. |
At 30 (+/- 4) hours after study drug
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Improvement in level of global disability measured by modified Rankin Score (mRS distribution)
時間枠:90 (±7) days
|
The modified Rankin Score assessment is a 7-level disability scale that measures the degree of disability or dependence in daily activities of people who have suffered a stroke. Range 0= no disability and 6=dead. |
90 (±7) days
|
|
Frequency of Modified Rankin (mRS) score of 0-1 or returning to pre-stroke mRS.
時間枠:Proportion of patients with modified Rankin scale score 0-1 or return to pre-stroke mRS at 90 (+/-7) days.
|
Proportion of patients with modified Rankin scale score 0-1 or return to pre-stroke mRS. |
Proportion of patients with modified Rankin scale score 0-1 or return to pre-stroke mRS at 90 (+/-7) days.
|
|
NIHSS
時間枠:72 (±12) hours (or at discharge if sooner) after study drug administration.
|
NIHSS is a stroke severity score that ranges from 0 to 42, with higher numbers indicating a more severe stroke. The NIHSS will be adjusted for the baseline value in analysis. |
72 (±12) hours (or at discharge if sooner) after study drug administration.
|
|
α2-antiplasmin (a2AP) level in plasma
時間枠:at 3 (±1) h after completion of study drug administration
|
A serine protease inhibitor responsible for inactivating plasmin. |
at 3 (±1) h after completion of study drug administration
|
|
Matrix metalloproteinase-9 level in plasma
時間枠:3 (±1) h after completion of study drug
|
An enzyme that regulates the pathological remodeling process that involve inflammation and fibrosis associated with cardiovascular disease. |
3 (±1) h after completion of study drug
|
|
% brain tissue reperfusion
時間枠:30 (±4) h after study drug administration
|
Proportion of brain tissue that is reperfused on the follow-up perfusion scan compared to the baseline, calculated as: ([baseline minus follow up perfusion imaging area of hypoperfusion]/ baseline area of hypoperfusion); hypoperfusion=T max>6 seconds |
30 (±4) h after study drug administration
|
|
Pharmacokinetic analyses
時間枠:3 (±1) h, 30 (±4) h, 30 (±5) days & 90 (±7) days after study drug administration. At 90 (±7) days for approximately 50 mITT participants. After approximately 50 mITT participants, it will be obtained at 72h(+12 hrs)/discharge visit, whichever comes 1st.
|
Measure of plasma concentrations of TS23 |
3 (±1) h, 30 (±4) h, 30 (±5) days & 90 (±7) days after study drug administration. At 90 (±7) days for approximately 50 mITT participants. After approximately 50 mITT participants, it will be obtained at 72h(+12 hrs)/discharge visit, whichever comes 1st.
|
|
Evaluation of anti-drug antibodies
時間枠:will be measured at baseline and 90 (±7) days follow-up visit for approximately 50 mITT participants.
|
commonly used for characterization of therapeutic antibodies |
will be measured at baseline and 90 (±7) days follow-up visit for approximately 50 mITT participants.
|
|
Proportion of patients with symptomatic intracerebral hemorrhage
時間枠:30 (±4) h of study drug administration
|
a blood clot large enough to cause significant neurological deterioration. |
30 (±4) h of study drug administration
|
|
Proportion of patients with non-intracerebral hemorrhage major or clinically relevant non-major bleeding
時間枠:30 days of study drug administration.
|
major and non-major events of bleeding that is not in the brain |
30 days of study drug administration.
|
|
Plasma fibrinogen level
時間枠:3 (±1) h after completion of study drug
|
Clotting factor |
3 (±1) h after completion of study drug
|
|
Proportion of patients with non-bleeding severe adverse events
時間枠:90 (±7) days
|
Assessment of untoward events |
90 (±7) days
|
|
Proportion of patients with stroke-related and all-cause deaths
時間枠:90 (±7) days
|
measure of important patient outcomes |
90 (±7) days
|
協力者と研究者
協力者
捜査官
- 主任研究者:Eva Mistry, MBBS、University of Cincinnati
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- TS23-U202
- UH3NS125023 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The SISTER trial will comply with the NIH Public Access Policy, which ensures that the public has access to the published results of NIH funded research, and the StrokeNet SOP (ADM 03) regarding results publication. Manuscripts and abstracts that use data from SISTER require approval from the Publication Committee of an original proposal before the concept may proceed. All publications will include this acknowledgement: "Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number [to be determined]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。