Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism

Embolic Stroke Clinical Trial

— SPACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090113
• Other study ID #: 2014ZX09201022-010-11
• Status: Completed
• Phase: Phase 4
• Start date: May 12, 2017
• Est. completion date: June 21, 2019

Study information

• Verified date: July 2020
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2416
• Est. completion date: June 21, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria

1. More than or equal to 18 years old and less than 80 years old;

2. Acute ischemic stroke, brain magnetic resonance imaging showed non lacunar infarction (subcortical infarction less than or equal to 1.5 cm);

3. Onset within 72 hours;

4. Patients or their family members are willing to sign the informed consent.

Exclusion criteria

1. Intracranial hemorrhage: cerebral hemorrhage, subarachnoid hemorrhage, etc.;

2. Transient ischemic attack;

3. Lacunar infarction;

4. History of acute stroke within 6 months;

5. Clear diagnosis of other causes of ischemic stroke (arterial dissection, arteritis, vasospasm, etc.);

6. The acute infarcts lesion more than one-half lobe in size;

7. Preceding modified Rankin Scale (mRS) score = 2;

8. 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;

9. Chronic liver disease, liver and kidney dysfunction, lifted alanine aminotransferase (>3 times the ULN), lifted serum creatinine (>2 times the ULN);

10. History of coagulopathy, systemic bleeding, thrombocytopenia or neutropenia;

11. Blood pressure >90/60 mmHg or =220/120 mmHg after treatment;

12. Serious heart or lung disease, in the judgment of clinical study staff, would not suitable to participant in the trial;

13. 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

14. 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;

15. Known allergies for ingredients of the drug, allergy history for food or drug;

16. Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;

17. Participation in another clinical trial within 30 days;

18. 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

1. History of atrial fibrillation

2. Atrial fibrillation in 12-lead electrocardiogram (ECG);

3. Heart rate monitoring (dynamic electrocardiogram telemetry) up to 20 hours or more detected atrial fibrillation for 6 minutes or more;

4. Intracardiac thrombosis in thoracic or esophageal echocardiography;

5. Occlusion or proximal vessel infarction for more than 50%.

Related Conditions & MeSH terms

• Embolic Stroke
• Embolism
• Recurrence

Intervention

Drug:
• Shuxuetong Injection
intravenous drip
• Placebo Injection
intravenous drip

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Baotou Medical College	Baotou	Neimenggu
China	Wu Yuan People's Hospital	Bayan Nur	Neimenggu
China	Ansteel Group Hospital	Beijing	Beijing
China	Beijing Tian Tan Hospital, Capital Medical University	Beijing	Beijing
China	Beiujing Fengtai Youanmen Hospital	Beijing	Beijing
China	The First Hospital of Fangshan District	Beijing	Beijing
China	Huimin People's Hospital	Binzhou	Shandong
China	Cangzhou Peoole's Hospital	Cangzhou	Hebei
China	People's Hospital of Hejian	Cangzhou	Hebei
China	The First Hospital of Jilin University-the Eastern Division	Changchun	Jilin
China	Kuancheng County Hospital	Chengde	Hebei
China	Affiliated Hospital of Chifeng University	Chifeng	Neimenggu
China	Yongchuan hospital of Traditional Chinese Medicine	Chongqing	Chongqing
China	Ningjin County People's Hospital	Dezhou	Shandong
China	Houjie Hospital	Dongguan	Guangzhou
China	Dongyang People's Hopital	Dongyang	Zhejiang
China	Handan Municipal Center Hospital	Handan	Henan
China	Traditional Chinese Medicine Hospital of Qiu County	Handan	Hebei
China	Hengshui Fourth Hospital	Hengshui	Hebei
China	Jizhou District Hospital of Hengshui	Hengshui	Hebei
China	The First Affiliated Hospital of University of South China	Hengyang	Henan
China	The Second People's Hospital of Huludao	Huludao	Liaoning
China	The Second Affiliated Hospital of Jiamusi University	Jiamusi	Heilongjiang
China	Shandong Provincial Western Hospital	Jinan	Shandong
China	Jingmen City Hospital of Traditional Chinese Medicine	Jingmen	Hubei
China	Jinzhou Medical University	Jinzhou	Liaoning
China	Lishui People's Hospital	Lishui	Zhejiang
China	Heilongjiang Province Agricultural Reclamation Mudanjiang Authority Central Hospital	Mudanjiang	Heilongjiang
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Jiangsu Province Hospital of TCM	Nanjing	Jiangsu
China	Nantong 3rd People's Hospital	Nantong	Jiangsu
China	People's Hospital of Penglai	Penglai	Shandong
China	People's Hospital of Qingdao West Coast New Area	Qingdao	Shandong
China	Qingdao Haci medical group hospital	Qingdao	Shandong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	The Second People's Hospital of Shenzhen	Shenzhen	Shenzhen
China	Shijiazhuang Pingan Hospital Affiliated to Hebei Medical University	Shijiazhuang	Hebei
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Zhangjiagang First People's Hospital	Suzhou	Jiangsu
China	Zhangjiagang Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine	Suzhou	Jiangsu
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	No.1 People's Hospital of Taizhou	Taizhou	Zhejiang
China	Ruian People's Hospital	Wenzhou	Zhejiang
China	Wuhan NO.1 Hospital,Wuhan Hospital Of Traditional Chinese And Western Medicine	Wuhan	Hubei
China	Wuhu No.1 People's Hospital	Wuhu	Anhui
China	The Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu
China	People's Hospital of Zhongmu	Zhengzhou	Henan
China	Zhengzhou Yihe Hospital Affiliated to Henan University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Detected an Atrial Fibrillation Persistent = 30s	Pre-specified Outcomes for Substudy of 'Etiology Study in Patients with ESUS'	90 days
Primary	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.	10 days
Secondary	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.	10 days
Secondary	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.	10 days
Secondary	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.	10 days
Secondary	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.	10 days
Secondary	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.	90 days
Secondary	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.	90 days
Secondary	Combined Vascular Events	Combined Vascular Events was defined as a combination of symptomatic stroke, myocardial infarction and vascular death.	90 days
Secondary	Disability or Death	Disability or Death was defined as a score of 3 to 6 on the modified Rankin Scale at 90days after onset.	90 days