Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy

NCT05700097 | Unknown Phase 2 DMC

• 1 other identifier: NCRC-2022-02
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the Efficacy and Safety of Dengzhanxixin Injection in Patients With Acute Ischemic Stroke Receiving Reperfusion Therapy.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Outcome

  Proportion of subjects of excellent outcome defined as modified Rankin Scale (mRS) (0-1) at 90 days. mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.

  90 days

• Primary Safety Outcome

  Proportion of patients with adverse events at 90 days.

  90 days

Secondary Outcomes (8)

• Infarction Volume

  14 days

• National Institutes of Health Stroke Scale (NIHSS)

  72 hours， 7 days， 14 days， 90days

• Excellent functional outcome

  14 days

• Modified Rankin Scale (mRS) distribution

  14 days， 90 days

• Barthel index (BI)

  90 days

Other Outcomes (1)

• Biomarkes

  14 days

Study Arms (3)

Low Dose Arm

EXPERIMENTAL

Dengzhanxixin injection 40ml/day, placebo 40ml/day. Dengzhanxixin injection 40ml, diluted with 250ml of 0.9% sodium chloride injection and then slowly intravenously infused once a day; placebo injection 40ml, diluted with 250ml of 0.9% sodium chloride injection and then slowly intravenously infused once a day.

Drug: Dengzhanxixin Injection

High Dose Arm

EXPERIMENTAL

Dengzhanxixin injection 80ml/day. Dengzhanxixin injection 40ml, diluted with 250ml of 0.9% sodium chloride injection, and then slowly intravenously infused twice a day.

Drug: Dengzhanxixin Injection

Placebo Arm

PLACEBO COMPARATOR

Placebo injection 80ml/day. Placebo injection 40ml, diluted with 250ml of 0.9% sodium chloride injection, and then slowly intravenously infused twice a day.

Drug: Placebo injection

Interventions

Dengzhanxixin Injection DRUG

Experimental arms for low, and high dose for the standard protocol

Also known as: Dengzhanxixin Zhusheye

High Dose Arm; Low Dose Arm

Placebo injection DRUG

placebo control arm for the standard protocol

Also known as: Placebo

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than or equal to 18 years old and less than 80 years old;
• Acute ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) of the head;
• Stroke onset within 24 hours and can be treated with study drug within 24 hours of symptoms onset；
• The patient has received or is planning to receive vascular reperfusion therapy after onset；
• Baseline NIHSS score is ≥4 and ≤26.
• mRS ≤1 prior onset.
• Informed consent signed.

You may not qualify if:

• Intracranial hemorrhage: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
• The acute infarcts lesion Involvement of more than one-third of middle cerebral artery (MCA) territory on initial brain imaging;
• Rapidly improving symptoms at the discretion of the investigator;
• Patients who have taken Dengzhanxixin Injection，edaravone or other brain protective drugs after onset ;
• History of intracranial hemorrhage；
• History of severe head trauma, stroke or myocardial infarction in past 3 months;
• Diagnosised intracranial tumor and giant intracranial aneurysm；
• Diagnosised aortic arch dissection；
• Undergoing major surgery within 2 weeks prior to screening; or intracranial or intraspinal surgery within 3 months prior to screening;
• Currently accompanied by active visceral bleeding; or arterial puncture at a site that is not easy to compress hemostasis within 1 week before screening; or gastrointestinal or urinary system bleeding occurred within 3 weeks before screening;
• Those with acute bleeding tendency, including: platelet count \<100×109/L, combined with hemophilia, etc.; or those with partially activated thrombin time greater than 3 times the upper limit of normal;
• Oral anticoagulants, and international normalized ratio\>1.7 or prothrombin time\>15s;
• Diagnosed primary liver and kidney disease, AST or ALT (\>2 times the ULN), serum creatinine \>2.0mg/dL or \>176.8µmol/L;
• Persistent blood pressure elevation ( systolic ≥180 mmHg or diastolic ≥100 mmHg ), despite blood pressure lowering treatment;
• Those with a history of epilepsy or epilepsy-like symptoms at the onset of stroke;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yongjun Wang, M.D.

  Beijing Tiantan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: January 26, 2023
• Study Start: September 30, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

CN (1)