NCT02728180

Brief Summary

The main purpose of this trial is to determine whether Xingnaojing, intravenously administered within 24 hours of symptom onset, improves the 3-month outcome in participants with acute ischemic stroke.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

3.8 years

First QC Date

March 28, 2016

Last Update Submit

October 2, 2019

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic StrokeXingnaojing injectionRandomized Controlled TrialTraditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients independent

    Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.

    90 days

Secondary Outcomes (8)

  • Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups.

    Baseline and 10 days.

  • Activities of daily living

    30 days and 90 days

  • Patient reported outcome (PRO) scale of stroke

    10 days

  • Early neurologic deterioration (END)

    Baseline and 48 hours

  • Symptomatic Intracranial Hemorrhage (sICH)

    10 dyas

  • +3 more secondary outcomes

Study Arms (2)

Xingnaojing and standard care

EXPERIMENTAL

Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.

Drug: Xingnaojing injectionOther: Standard care

Standard care only

ACTIVE COMPARATOR

Subjects will receive guidelines-based standard care only.

Other: Standard care

Interventions

Xingnaojing injectionDRUG

Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.

Xingnaojing and standard care
Standard careOTHER

Guidelines-based standard care for acute ischemic stroke.

Standard care onlyXingnaojing and standard care

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute ischemic stroke within 24 hours of symptom onset.
  • National Institutes of Health Stroke Scale score ≥ 5 and ≤ 20.
  • Age ≥ 35 and ≤ 80 years.
  • Patient or legally authorized representative has signed informed consent.

You may not qualify if:

  • Planned or already received endovascular treatment.
  • Suspected secondary stroke caused by tumor, brain trauma, or hematologic diseases.
  • Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 ).
  • Other conditions that lead to motor dysfunction (e.g. severe osteoarthrosis, rheumatoid arthritis).
  • Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase, or aspartate aminotransferase value that is twice greater than the upper limit of normal).
  • Life expectancy of 90 days or less due to other life threatening illness (e.g. advanced cancer).
  • Other conditions that render outcomes or follow-up unlikely to be assessed..
  • Known to be pregnant or breastfeeding.
  • Currently receiving an investigational drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

Location

Related Publications (1)

  • Lai X, Cao K, Kong L, Liu Q, Gao Y; XMAS study investigators. Xingnaojing for Moderate-to-severe Acute ischemic Stroke (XMAS): study protocol for a randomized controlled trial. Trials. 2017 Oct 16;18(1):479. doi: 10.1186/s13063-017-2222-y.

    PMID: 29037226BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

xingnaojingStandard of Care

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Ying Gao, MD

    Dongzhimen Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Dongzhimen Hospital

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 5, 2016

Study Start

March 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

October 4, 2019

Record last verified: 2019-10

Locations

CN(1)