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Acute Ischemic StrokePhase 3NCT02430350

Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

A Phase 3 study testing Compound Edaravone Injection and Edaravone Injection in people with Acute Ischemic Stroke, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 48 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Compound Edaravone Injection and Edaravone Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
48 sitesChina
Study dates
May 2015to Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hospitalized patients, diagnosed of ischemic stroke;
  • Onset of stroke is less than or equal to 48 hours;
  • There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
  • Patients signed written inform consent

Who cannot join

  • Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
  • Iatrogenic stroke;
  • Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
  • The mRS score prior to this onset is greater than 1;
  • Transient ischemic attack (TIA);
  • SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;
Show all 18Show fewer
  • Patients with severe mental disorders and dementia;
  • ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
  • Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases;
  • Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
  • Arterial or venous thrombolytic therapy has been applied after onset of stroke;
  • Patients with malignant tumors or receiving concurrent antitumor treatment;
  • Patients with severe systemic disease, life expectancy is less than 90 days;
  • allergic to edaravone , (+)-Borneol or related excipients;
  • Pregnant or lactating women;
  • Have major surgery within 4 weeks before enrollment;
  • Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present;
  • The investigators consider the patients are not suitable for this trial.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

China48 sites

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 014010

  • The Third Affiliated Hospital of Inner Mongolia Medical University

    Baotou, Inner Mongolia, 014010

  • Central Hospital of Baotou

    Baotou, Inner Mongolia, 014040

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Navy General Hospital of The Chinese PLA

    Beijing, Beijing Municipality, 100048

  • Beijing Tian Tan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061000

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541001

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • The Second Affiliated Hospital of Haerbin Medical University

    Haerbin, Heilongjiang, 150001

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan, 421001

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia, 010017

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

  • Huai'an First Affiliated Hospital of Nanjing Medical University

    Huai'an, Jiangsu, 223300

  • The Sceond Hospital of Shandong University

    Jinan, Shandong, 250033

  • Lianyungang First People's Hospital

    Lianyungang, Jiangsu, 222002

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • Lishui People's Hospital

    Lishui, Zhejiang, 323000

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi, 545005

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • Zhongda Hospital,Southeast University

    Nanjing, Jiangsu, 210009

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Nanjing Brain Hospital

    Nanjing, Jiangsu, 210029

  • Nanning Second People's Hospital

    Nanning, Guangxi, 530031

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266011

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • Yangpu Hospital, Tongji University

    Shanghai, Shanghai Municipality, 200090

  • The General Hospital of Shenyang Military, Chinese PLA

    Shenyang, Liaoning, 110016

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • The Forth Hospital of Jilin University

    Siping, Jilin, 130011

  • Siping Central Hospital

    Siping, Jilin, 136000

  • The Second Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300060

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu, 221006

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

  • Yangzhou No.1 People's Hospital

    Yangzhou, Jiangsu, 225001

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial

The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.

Being tested
Compound Edaravone Injection, Edaravone Injection
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compound Edaravone InjectionDrug

  • Edaravone InjectionDrug

Study groups in NCT02430350
Study groupRoleWhat they receive
Compound EdaravoneExperimentalCompound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
Receives: Drug: Compound Edaravone Injection
EdaravoneActive comparatorEdaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days
Receives: Drug: Edaravone Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients with mRS ≤1 on day 90

    Measured: day 90

Secondary outcomes (6)

  1. mRS score on day 90

    Measured: day 90

  2. Changes of NIHSS score from baseline on day 14

    Measured: day 14

  3. The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90

    Measured: day 14, 30, 90

  4. The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90

    Measured: day 14, 30, 90

  5. Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90

    Measured: day 14, 30, 90

  6. Stroke Impact Scale (SIS) score on day 90

    Measured: day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02430350
Sponsor's protocol ID
SIM-23-02
Status last verified
Jan 2017
First submitted
20 Apr 2015
Last updated
16 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.

    PubMed 33588596

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Compound Edaravone Injection and Edaravone Injection in people with Acute Ischemic Stroke, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 48 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients with mRS ≤1 on day 90 (time frame: day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02430350, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.

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