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Embolic StrokePhase 4SPACENCT03090113

Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism

A Phase 4 study testing Shuxuetong Injection in people with Embolic Stroke, run by Beijing Tiantan Hospital 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

This is a randomized, double blind, placebo-controlled, parallel, multicenter research in order to evaluate the effect of Shuxuetong injection in prevention of symptomatic or asymptomatic new cerebral infarction within 10 days. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Embolic Stroke
What is being tested?
Shuxuetong Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,416 participants
Where
48 sitesChina
Study dates
12 May 2017to 21 Jun 2019
Phase
Phase 4
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • More than or equal to 18 years old and less than 80 years old;
  • Acute ischemic stroke, brain magnetic resonance imaging showed non lacunar infarction (subcortical infarction less than or equal to 1.5 cm);
  • Onset within 72 hours;
  • Patients or their family members are willing to sign the informed consent.

Who cannot join

  • Intracranial hemorrhage: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
  • Transient ischemic attack;
  • Lacunar infarction;
  • History of acute stroke within 6 months;
  • Clear diagnosis of other causes of ischemic stroke (arterial dissection, arteritis, vasospasm, etc.);
  • The acute infarcts lesion more than one-half lobe in size;
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  • Preceding modified Rankin Scale (mRS) score ≥ 2;
  • Cumulative usage of traditional Chinese medicine which activating blood circulation more than 3 times after onset, including but not limited to: Danhong, Xueshuantong, Xuesaitong, Ginkgo biloba, sodium ozagrel, Salvia miltiorrhiza, ligustrazine, Erigeron breviscapus, etc;
  • Chronic liver disease, liver and kidney dysfunction, lifted alanine aminotransferase (>3 times the ULN), lifted serum creatinine (>2 times the ULN）;
  • History of coagulopathy, systemic bleeding, thrombocytopenia or neutropenia;
  • Blood pressure >90/60 mmHg or ≤220/120 mmHg after treatment;
  • Serious heart or lung disease, in the judgment of clinical study staff, would not suitable to participant in the trial;
  • Patients with atrial fibrillation who were scheduled or likely to receive anticoagulant therapy with unfractionated heparin or low molecular weight heparin within 2 weeks after randomization
  • A medical condition likely to limit survival to less than three months or any other condition judged by the clinic team to likely limit the adherence to study procedures;
  • Known allergies for ingredients of the drug, allergy history for food or drug;
  • Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;
  • Participation in another clinical trial within 30 days;
  • Unable to understand and/or comply with the study procedures and/or follow-up studies due to mental illness, cognitive or emotional disorders.
  • Subgroup Exclusion Criteria
  • History of atrial fibrillation
  • Atrial fibrillation in 12-lead electrocardiogram (ECG);
  • Heart rate monitoring (dynamic electrocardiogram telemetry) up to 20 hours or more detected atrial fibrillation for 6 minutes or more;
  • Intracardiac thrombosis in thoracic or esophageal echocardiography;
  • Occlusion or proximal vessel infarction for more than 50%.

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, Neimenggu

  • Wu Yuan People's Hospital

    Bayan Nur, Neimenggu

  • Beijing Tian Tan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Ansteel Group Hospital

    Beijing, Beijing Municipality

  • Beiujing Fengtai Youanmen Hospital

    Beijing, Beijing Municipality

  • The First Hospital of Fangshan District

    Beijing, Beijing Municipality

  • Huimin People's Hospital

    Binzhou, Shandong

  • Cangzhou Peoole's Hospital

    Cangzhou, Hebei

  • People's Hospital of Hejian

    Cangzhou, Hebei

  • The First Hospital of Jilin University-the Eastern Division

    Changchun, Jilin

  • Kuancheng County Hospital

    Chengde, Hebei

  • Affiliated Hospital of Chifeng University

    Chifeng, Neimenggu

  • Yongchuan hospital of Traditional Chinese Medicine

    Chongqing, Chongqing Municipality

  • People's Hospital of Penglai

    Dengzhou, Shandong

  • Ningjin County People's Hospital

    Dezhou, Shandong

  • Houjie Hospital

    Dongguan, Guangzhou

  • Dongyang People's Hopital

    Dongyang, Zhejiang

  • Traditional Chinese Medicine Hospital of Qiu County

    Handan, Hebei

  • Handan Municipal Center Hospital

    Handan, Henan

  • Hengshui Fourth Hospital

    Hengshui, Hebei

  • Jizhou District Hospital of Hengshui

    Hengshui, Hebei

  • The First Affiliated Hospital of University of South China

    Hengyang, Henan

  • The Second People's Hospital of Huludao

    Huludao, Liaoning

  • The Second Affiliated Hospital of Jiamusi University

    Jiamusi, Heilongjiang

  • Shandong Provincial Western Hospital

    Jinan, Shandong

  • Jingmen City Hospital of Traditional Chinese Medicine

    Jingmen, Hubei

  • Jinzhou Medical University

    Jinzhou, Liaoning

  • Lishui People's Hospital

    Lishui, Zhejiang

  • Heilongjiang Province Agricultural Reclamation Mudanjiang Authority Central Hospital

    Mudanjiang, Heilongjiang

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • Jiangsu Province Hospital of TCM

    Nanjing, Jiangsu

  • Nantong 3rd People's Hospital

    Nantong, Jiangsu

  • People's Hospital of Qingdao West Coast New Area

    Qingdao, Shandong

  • Qingdao Haci medical group hospital

    Qingdao, Shandong

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • The Second People's Hospital of Shenzhen

    Shenzhen, Shenzhen

  • Shijiazhuang Pingan Hospital Affiliated to Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Zhangjiagang First People's Hospital

    Suzhou, Jiangsu

  • Zhangjiagang Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine

    Suzhou, Jiangsu

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • No.1 People's Hospital of Taizhou

    Taizhou, Zhejiang

  • Ruian People's Hospital

    Wenzhou, Zhejiang

  • Wuhan NO.1 Hospital,Wuhan Hospital Of Traditional Chinese And Western Medicine

    Wuhan, Hubei

  • Wuhu No.1 People's Hospital

    Wuhu, Anhui

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu

  • People's Hospital of Zhongmu

    Zhengzhou, Henan

  • Zhengzhou Yihe Hospital Affiliated to Henan University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Random, Double-blind, Parallel, Placebo-controlled, Multi-center Study of Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism

This is a randomized, double blind, placebo-controlled, parallel, multicenter research in order to evaluate the effect of Shuxuetong injection in prevention of symptomatic or asymptomatic new cerebral infarction within 10 days.

Subgroup study：Evaluate the role of advanced diagnostic technique in identifying potential causes of Embolic Stroke of Undetermined Source (ESUS).

Read the detailed description

Shuxuetong injection or Placebo injection for 10days. About 2416 patients randomized at 80 centers all over China with 20 subgroup study centers.

Face to face interview at baseline, 10 days, and 90 days.

Conditions
Embolic Stroke
Being tested
Shuxuetong Injection, Placebo Injection
Keywords
Stroke, Embolic Stroke, Shuxuetong, Recurrence, Symptomatic New Cerebral Infarction, Asymptomatic New Cerebral Infarction
Medical subject headings
Embolic Stroke, Stroke, Recurrence

What participants receive

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

  • Shuxuetong InjectionDrug

    Also called Shuxuetong

    intravenous drip

  • Placebo InjectionDrug

    Also called Placebo

    intravenous drip

Study groups in NCT03090113
Study groupRoleWhat they receive
Shuxuetong InjectionExperimentalShuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;
Receives: Drug: Shuxuetong Injection
Placebo InjectionPlacebo comparatorPlacebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;
Receives: Drug: Placebo Injection

What is being measured

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

  1. Symptomatic or Asymptomatic New Cerebral Infarction

    Those patients who are still alive at 10 days after randomization will be contacted to set up a follow-up clinical visit. Information of recurrent symptomatic cerebral infarction will be collected and MRI examination will be performed to detect asymptomatic new cerebral infarction.

    Measured: 10 days

Secondary outcomes (8)

  1. Symptomatic Cerebral Infarction

    Those patients who are still alive at 10 days after randomization will be contacted to set up a follow-up clinical visit. Information of recurrent symptomatic cerebral infarction will be collected.

    Measured: 10 days

  2. Asymptomatic Cerebral Infarction

    Those patients who are still alive at 10 days after randomization will be contacted to set up a follow-up clinical visit. MRI examination including diffusion weighted imaging (DWI) sequence will be performed.

    Measured: 10 days

  3. Cerebral Infarction Volume Expansion

    Those patients who are still alive at hospital discharge will be contacted to set up a follow-up clinical visit. MRI examination will be performed.

    Measured: 10 days

  4. NIHSS Score Increase

    Those patients who are still alive at hospital discharge will be contacted to set up a follow-up clinical visit. Neurological and functional assessments including NIHSS will be performed.

    Measured: 10 days

  5. Recurrent Symptomatic Stroke(Cerebral infarction, cerebral hemorrhage)

    Those patients who are still alive at 90days after onset will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent symptomatic stroke will be collected.

    Measured: 90 days

  6. Recurrent Symptomatic Ischemic Stroke

    Those patients who are still alive at 90days after onset will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent symptomatic ischmemic stroke will be collected.

    Measured: 90 days

  7. Combined Vascular Events

    Combined Vascular Events was defined as a combination of symptomatic stroke, myocardial infarction and vascular death.

    Measured: 90 days

  8. Disability or Death

    Disability or Death was defined as a score of 3 to 6 on the modified Rankin Scale at 90days after onset.

    Measured: 90 days

Timeline

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

  1. First posted24 Mar 2017
  2. Study start12 May 2017
  3. Primary completion30 Mar 2019
  4. Study completion21 Jun 2019

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03090113
Sponsor's protocol ID
2014ZX09201022-010-11
Acronym
SPACE
Status last verified
Jul 2020
First submitted
9 Mar 2017
Last updated
22 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gu HQ, Xie XW, Jing J, Meng X, Lv W, Yu JD, Lv XP, Li H, Wang YL, Wang YJ. Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial: rationale and design. Stroke Vasc Neurol. 2020 Sep;5(3):311-314. doi: 10.1136/svn-2019-000293. Epub 2020 Feb 27.

    PubMed 32994371

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Shuxuetong Injection in people with Embolic Stroke, run by Beijing Tiantan Hospital 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 24 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 22 Jul 2020. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Symptomatic or Asymptomatic New Cerebral Infarction (time frame: 10 days). 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 NCT03090113, 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 22 Jul 2020.

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