Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Intra-arterial Cocktail Therapy (INSIST-CT)

Ischemic Stroke Clinical Trial

Official title:

Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Intra-arterial Cocktail Therapy (INSIST-CT): a Prospective, Single Arm, Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202549
• Other study ID #: k(2019)31
• Status: Completed
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: September 20, 2022

Study information

• Verified date: November 2023
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. Although sufficient recanalization after thrombectomy is more than 80%, HERMES study indicated that nearly half of the ischemic stroke patients under thrombectomy suffered obvious disability. Artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon are among the most important reasons of poor prognosis of acute ischemic stroke patients. The investigators speculate that a combination of argatroban, edaravone, and glucocorticoid may be helpful in preventing artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon. This study intends to explore the safety, feasibility and efficacy of thrombectomy with sufficient recanalization bridged by intra-arterial cocktail therapy in acute ischemic stroke patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years.

2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy.

3. Sufficient recanalization (TICI 2b-3)within 7 hours of stroke onset.

4. The availability of informed consent.

Exclusion Criteria:

1. insufficient recanalization(TICI < 2a)after endovascular treatment;

2. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage.

4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia ( <100000/mm3).

5. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis.

6. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).

7. Patients with contraindication or allergic to any ingredient of drugs in our study.

8. Unsuitable for this clinical studies assessed by researcher.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• intra-arterial cocktail therapy
Intra-arterial administration of argatroban (0.2-0.3 mg/min), dexamethasone (0.1 mg/min) and edaravone (0.3 mg/min) for 30 to 60 minutes after thrombectomy.

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command	ShenYang

Sponsors (1)

Lead Sponsor	Collaborator
Hui-Sheng Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence of symptomatic intracranial haemorrhage	intracranial haemorrhage is defined as more than 4 increase in NIHSS caused by intracranial bleeding	48 hours
Primary	Proportion of favorable outcome	favorable outcome is defined as mRS 0-2	90 days
Secondary	Proportion of excellent outcome	excellent outcome is defined as mRS 0-1	90 days
Secondary	proportion of early neurological improvement	early neurological improvement is defined as more than 4 decrease in NIHSS	48 hours