NCT03733223

Brief Summary

The primary aim of the study is to investigate the relationships among FVIII, t-PA/PAI-1, MMP-9 levels, and intracranial hemorrhage after thrombolysis with alteplase using a combined analysis.

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
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

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

October 12, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

November 5, 2018

Last Update Submit

March 17, 2019

Conditions

Ischemic Stroke

Keywords

t-PA/PAI-1MMP-9FVIIIAlteplaseintracranial haemorrhageIschemic stroke

Outcome Measures

Primary Outcomes (1)

  • Intracranial hemorrhage

    The occurrence of intracranial haemorrhage adverse reactions in ischemic stroke patients receiving thrombolytic therapy by alteplase

    3 days

Study Arms (2)

experimental group

The patients who were treated with Ateptidase had intracranial haemorrhage adverse reactions

Drug: Ateptidase

control group

The patients who were treated with Ateptidase did not have intracranial haemorrhage adverse reactions.

Drug: Ateptidase

Interventions

AteptidaseDRUG

Treatment of ischemic stroke with Ateptidase

control groupexperimental group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ischemic stroke treated with Alteplase

You may qualify if:

  • Diagnosis of ischemic stroke and within the time window of thrombolysis (Onset of symptoms no more than 4.5 hours )
  • y age 85 y•
  • Symptoms of neurological deficits caused by cerebral infarction
  • Informed consent form to confirm thrombolytic therapy have signed by patients or their family.

You may not qualify if:

  • A history of major head trauma or stroke in the past 3 months
  • Suspicious subarachnoid hemorrhage
  • Arterial puncture at noncompressible site in the last week
  • History of intracranial hemorrhage
  • Intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Recent intracranial or intraspinal surgery
  • Elevated blood pressure (systolic \>185 mm Hg or diastolic \>110 mm Hg)
  • Active internal bleeding or Acute bleeding diathesis
  • Platelet count \<100×109·L-1
  • Heparin received within 48 h resulting in aPTT above the upper limit of normal
  • Current use of anticoagulant with INR \>1.7 or PT \>15 s
  • Current use of thrombin inhibitors or factor Xa inhibitors
  • Abnormal laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
  • Blood glucose concentration \> 2.7 mmol/L
  • CT demonstrates multilobar infarction (hypodensity \>1/3 cerebral hemisphere)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

Related Publications (1)

  • Wang Y, Liao X, Zhao X, Wang DZ, Wang C, Nguyen-Huynh MN, Zhou Y, Liu L, Wang X, Liu G, Li H, Wang Y; China National Stroke Registry Investigators. Using recombinant tissue plasminogen activator to treat acute ischemic stroke in China: analysis of the results from the Chinese National Stroke Registry (CNSR). Stroke. 2011 Jun;42(6):1658-64. doi: 10.1161/STROKEAHA.110.604249. Epub 2011 Apr 21.

    PMID: 21512182RESULT

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Ischemic StrokeIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shuai He, Doctor

    Southern Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuai He, Doctor

CONTACT

862062783372hs43555@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

October 12, 2018

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

March 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)