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Post-marketing Clinical Confirmation Study of Cinepazide Maleate Injection for Acute Ischemic Stroke: a Randomized, Double-blinded, Multicenter, Placebo-parallel Controlled Trial

Post-marketing Clinical Confirmation Study of Cinepazide Maleate Injection for Acute Ischemic Stroke: a Randomized, Double-blinded, Multicenter, Placebo-parallel Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023827
Enrollment
Unknown
Registered
2019-06-13
Start date
2016-04-15
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke

Interventions

experimental group:Cinepazide Maleate Injection

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years; 2. Diagnosed with first-ever acute ischemic stroke with Anterior circulation infarction according to Chinese Acute Ischemic Stroke Diagnosis and Teatment Guideline (2014 version); 3. First episode or relapsed ischemic stroke with a score of 0-1 on mRS, within 48 hours of onset; 4. Had a score of 7-25 points on the NIHSS; 5.Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. ralapsed cerebral infarction with a score =2 points on the Mrs; 2. head CT indicated intracranial hemorrhagic diseases (e.g., hemorrhagic stroke, epidural hematoma,intracranial hematoma, Intraventricular hemorrhage, subarachnoid hemorrhage; 3. cerebral infarction with disturbance of conscious(NIHSS scores 1a =1 point),TIA, Cerebral arteritis,brain tumour, brain trauma, intracranial infection, brain parasitic; 4. had or need to undergo interventional therapy, thrombolysis, defibrase therapy; 5. had any of the following diseases history at baseline: (1) high blood pressure without good control, baseline systolic pressure=200mmHg, or diastolic blood pressure=110mmHg; (2) with high risk of cardiogenic embolism(e.g., combined with rheumatic heart disease, atrial fibrillation, Cardiac valve disease, or ventricular aneurysm; (3) had acute ischemic stroke or interventional therapy within 6 months; (4) heart failure (baseline NYHA grading III-IV grade); (5) had bleeding tendency or serious bleeding within 3 months; (6) epilepsy; (7) combined with malignant tumour, hematological system, digestive system or other system serious diseases or progressive diseases; (8) combined with other mental diseases that cannot participate in the study; 6. had any of the following lab index: (1) blood routine test indicate: white cells < the lower range value of reference values; (2) had liver and renal dysfunction: ALT or AST exceeding a 1.5-fold upper range value, Cr exceeding a 1.2-fold upper range value; (3) other abnormal lab test with clinical values which was determined to exclude from the study by investigator; 7. allergic constitution or allergic to the study drugs; 8. alcohol or drug abuse history; 9. pregnant or lactating women; 10. expected life time lower than 3 months; 11. participated in other clinical trials within 3 months; 12. other conditions that investigators determined not suitable for this study.

Design outcomes

Primary

MeasureTime frame
mRS;

Secondary

MeasureTime frame
NIHSS;Barthel Index;

Countries

China

Contacts

Public ContactLiying Cui

Peking Union Medical College Hospital

liuping831120@yeah.net+86 18500873366

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026