Clinical Research of Intravenous Thrombolysis for Ischemic Stroke in Northeast of China

Ischemic Stroke Clinical Trial

— CRISTINA  

Official title:

Clinical Research of Intravenous Thrombolysis for Ischemic Stroke in Northeast of China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05028868
• Other study ID #: CRISTINA
• Status: Recruiting
• Start date: June 1, 2015
• Est. completion date: January 28, 2026

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD,PhD
• Email: doctor_yangyi[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

With the highest incidence rate,the population in northeast of China is severely tormented by stroke, especially ischemic stroke. The investigators lunch this project by building up a database of detailed information of patients that fits the criteria of intravenous thrombolysis therapy.Including biochemical markers,imaging and follow-up,investigators intend to analysis these data,find factors that contributes to better prognosis,so as to push forward the prevention and control work.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 28, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of ischemic stroke causing measurable neurological deficit

2. Onset of symptoms <4.5 h before treatment begins

3. Age =18 y

Exclusion Criteria:

1. Significant head trauma or prior stroke in the previous 3 mo

2. Symptoms suggest SAH

3. Arterial puncture at noncompressible site in previous 7 d

4. History of previous intracranial hemorrhage

5. Intracranial neoplasm, AVM, or aneurysm

6. Recent intracranial or intraspinal surgery

7. Elevated blood pressure (systolic >185 mm Hg or diastolic >110 mm Hg)

8. Active internal bleeding

9. Acute bleeding diathesis, including but not limited to

10. Platelet count <100 000/mm3

11. Heparin received within 48 h resulting in abnormally elevated aPTT above the upper limit of normal

12. Current use of anticoagulant with INR >1.7 or PT >15 s

13. 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)

14. Blood glucose concentration <50 mg/dL (2.7 mmol/L)

15. CT demonstrates multilobar infarction (hypodensity >1/3 cerebral hemisphere)

16. Relative exclusion criteria

17. Recent experience suggests that under some circumstances, with careful consideration and weighting of risk to benefit, patients may receive fibrinolytic therapy despite =1 relative contraindications. Consider risk to benefit of intravenous rtPA administration carefully if any of these relative contraindications is present

18. Only minor or rapidly improving stroke symptoms (clearing spontaneously)

19. Pregnancy

20. Seizure at onset with postictal residual neurological impairments

21. Major surgery or serious trauma within previous 14 d

22. Recent gastrointestinal or urinary tract hemorrhage (within previous 21 d)

23. Recent acute myocardial infarction (within previous 3 mo)

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke
• Thrombosis

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mRS score in 90 days	Using mRS score to evaluate the effective of thrombolysis among different groups.	90 days
Primary	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	Cardiovascular death in 1 year	Death direct from ischemic stroke, hemorrhagic stroke, sudden cardiac death, acute myocardial infarction, heart failure, and other cardiovascular death including cardiac arrhythmia that unrelated to sudden cardiac death, pulmonary embolism, cardiovascular intervention (unrelated to acute MI), ruptured aortic aneurysm, or peripheral arterial disease).	1 year
Secondary	Post-stroke disability in 1 year	modified Rankin Scale(mRS)=3	1 year