Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

NCT03997292 | Withdrawn DMC FDA Drug

• 1 other identifier: K201707
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China

Conditions

Ischemic Stroke

Keywords

alteplase; urokinase; intravenous thrombolysis

Outcome Measures

Primary Outcomes (1)

• mRS of 90 days after thrombolysis

  Proportion of patients with mRS = 0-1 points 90 days after thrombolysis

  Month 3

Secondary Outcomes (1)

• Evaluation of Adverse events

  Year 1

Other Outcomes (1)

• Economic evaluation

  Day 14

Study Arms (2)

Alteplase group

According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion

Drug: Alteplase

Urokinase group

1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously End

Drug: Urokinase

Interventions

Alteplase DRUG

According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion.

Alteplase group

Urokinase DRUG

1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.

Urokinase group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thrombolytic patients with acute ischemic stroke within 3 hours of onset

You may qualify if:

• \) age\> 18 years old;
• \) meet the diagnostic criteria of China 2014 guidelines for the diagnosis and treatment of acute ischemic stroke;
• \) no history of first sepsis or previous cerebral infarction sequelae (mRS ≤ 1);
• \) within 3 hours of onset;
• \) Have measurable neurological deficits;
• \) Patients or legal guardians can understand and sign informed consent.

You may not qualify if:

• \) history of head trauma or stroke within the last 3 months;
• \) suspected subarachnoid hemorrhage;
• \) history of previous intracranial hemorrhage;
• \) intracranial tumor, arteriovenous malformation or aneurysm ;
• \) recent intracranial or intraspinal surgery;
• \) arterial puncture at an incurable site within the last 7 days;
• \) elevated blood pressure: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
• \) Internal bleeding;
• \) acute bleeding tendency, including platelet count less than 100 × 109 / L or other conditions;
• \) heparin treatment within 48 h (APTT is outside the upper limit of normal range);
• \) oral anticoagulant, INR\> 1.7 Or PT\> 15S;
• \) are currently using thrombin inhibitors or factor Xa inhibitors, various sensitive laboratory abnormalities (such as APTT, INR, platelet count, ECT; TT or appropriate factor Xa activity assays) ;
• \) Blood glucose \<50 mg / dl (2.7 mmol / L);
• \) CT suggestive of multiple cerebral infarction (low density range\> 1/3 of the cerebral hemispheres) ;
• \) 3 months or are participating in other clinical trials;

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Shenyang Military Region

Shenyang, Liaoning, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tissue Plasminogen Activator; Urokinase-Type Plasminogen Activator

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Huisheng Chen, doctor

  Neurology Chief

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology Chief

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: June 25, 2019
• Study Start: March 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

CN (1)