NCT05028868

Brief Summary

This research is based on clinic treatment of intravenous thrombolysis for patients with acute ischemic stroke.By building up a database of these patients, the investigators aim to find some significance between groups by analyzing population information, clinical status and such for better evaluation and optimal treatment decision.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2026

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

9.8 years

First QC Date

March 7, 2017

Last Update Submit

February 29, 2024

Conditions

Ischemic StrokeThrombosis

Keywords

ischemic strokethrombolysis

Outcome Measures

Primary Outcomes (2)

  • mRS score in 90 days

    Using mRS score to evaluate the effective of thrombolysis among different groups.

    90 days

  • Stroke recurrence within 90 days

    Newly onset stroke that the time interval was less than 90 days from the original stroke event was considered as stroke recurrence. Ischemic stroke was defined as acute focal brain or retinal infarction.

    90 days

Secondary Outcomes (2)

  • Cardiovascular death in 1 year

    1 year

  • Post-stroke disability in 1 year

    1 year

Study Arms (5)

Large artery atherosclerosis(LAA)

Cardiogenic stroke(CS)

Penetrating artery disease(PAD)

Other etiology(OE)

undetermined etiology(UE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute ischemic stroke within 4.5h from symptoms onset who received IV rt-PA.

You may qualify if:

  • Diagnosis of ischemic stroke causing measurable neurological deficit
  • Onset of symptoms \<4.5 h before treatment begins
  • Age ≥18 y

You may not qualify if:

  • Significant head trauma or prior stroke in the previous 3 mo
  • Symptoms suggest SAH
  • Arterial puncture at noncompressible site in previous 7 d
  • History of previous intracranial hemorrhage
  • Intracranial neoplasm, AVM, or aneurysm
  • Recent intracranial or intraspinal surgery
  • Elevated blood pressure (systolic \>185 mm Hg or diastolic \>110 mm Hg)
  • Active internal bleeding
  • Acute bleeding diathesis, including but not limited to
  • Platelet count \<100 000/mm3
  • Heparin received within 48 h resulting in abnormally elevated aPTT above the upper limit of normal
  • Current use of anticoagulant with INR \>1.7 or PT \>15 s
  • Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
  • Blood glucose concentration \<50 mg/dL (2.7 mmol/L)
  • CT demonstrates multilobar infarction (hypodensity \>1/3 cerebral hemisphere)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Related Publications (1)

  • Zhang HM, Shen ZD, Qu Y, Zhang P, Abuduxukuer R, Wang LJ, Li Y, Chen YM, Liu AR, Liu XD, Zhao LL, Yang CY, Yao J, Wang AY, Jiang YF, Wang JC, Dong CP, Liu FF, Li L, Qi YB, Wang CF, Li H, Zhang LY, Ma WJ, Guo ZN, Yang Y. External validation of N2H3 nomogram to predict outcomes in patients with acute ischemic stroke treated by intravenous thrombolysis. Brain Circ. 2025 Mar 4;11(3):212-218. doi: 10.4103/bc.bc_81_24. eCollection 2025 Jul-Sep.

    PMID: 40842451DERIVED

MeSH Terms

Conditions

Ischemic StrokeThrombosis

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Study Officials

  • Yi Yang, MD，PhD

    The First Hospital of Jilin University

    STUDY CHAIR

Central Study Contacts

Yi Yang, MD，PhD

CONTACT

doctor_yangyi@hotmail.com

Zhenni Guo, MD

CONTACT

zhen1ni2@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate dean, Director of Cerebrovascular Disease Center

Study Record Dates

First Submitted

March 7, 2017

First Posted

August 31, 2021

Study Start

June 1, 2015

Primary Completion

February 28, 2025

Study Completion

January 28, 2026

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations

CN(1)