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The clinical time-effect study of combined application of Xingnao Kaiqiao therapy and mechanical recanalization in the treatment of acute ischemic stroke patients with large vessel occlusion

The clinical time-effect study of combined application of Xingnao Kaiqiao therapy and mechanical recanalization in the treatment of acute ischemic stroke patients with large vessel occlusion

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004067
Enrollment
Unknown
Registered
2020-11-21
Start date
2020-12-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke

Interventions

Control group:Normal saline

Sponsors

Dongfang Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Clinical diagnosis of acute ischemic stroke, the clinical symptoms or signs are considered to be caused by intracranial and extracranial large artery occlusion. Hospitals with conditions recommend non-invasive imaging examination to confirm the diagnosis of the responsible large vessel occlusion; 3. Neurological deficit score (NIHSS) >=6 points; ASPECT score >=6 points; 4. The time from the onset of the anterior circulation to the completion of femoral artery puncture is within 6 hours. If there is an obvious ischemic penumbra, the thrombus removal time window can be extended to 6~24 hours according to the patient's condition; 5. It is reasonable to perform post-circulation mechanical thrombectomy therapy; 6. CT or MR examination to rule out intracranial hemorrhage and large-scale cerebral infarction. A large area cerebral infarction in the anterior circulation is defined as CT or DW imaging, ASPECTST score =70ml, or infarct volume >1/3 of the middle cerebral artery blood supply area; a large area cerebral infarction in the posterior circulation is defined as infarct volume> 1/3 brainstem volume.

Exclusion criteria

Exclusion criteria: 1. Hemorrhagic constitution or receiving anticoagulation treatment, including coagulation factor deficiency disease, international normalized ratio (INR)>1.7; 2. Active bleeding or major surgery in the past 2 weeks, significant trauma or bleeding disease; 3. The modified Rankini scale score (mRs) of the patients before the stroke occurred>3; 4. Seriously allergic to contrast agents; 5. Refractory hypertension that cannot be controlled by drugs (continuous systolic blood pressure >=185mmg, or continuous diastolic blood pressure >=110mmHg); 6. Blood sugar 22.0mimo/L; 7. The platelet count is less than 100x19/L; 8. Serious heart, liver and kidney function abnormalities; 9. Pregnancy; 10. Suspected infectious emboli, such as septic emboli or bacterial endocarditis; 11. End-stage disease leads to life expectancy of patients <3 months.

Design outcomes

Primary

MeasureTime frame
NIHSS score;

Countries

China

Contacts

Public ContactLe Wang

Beijing University of Chinese Medicine

13661172704@139.com+86 10 87611372

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026