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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: intra-arterial cocktail therapy

• Registration Number: NCT04202549
• Lead Sponsor: Hui-Sheng Chen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-15
• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-15
• Study First Posted: 2019-12-17
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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

4. 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.

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

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

7. Unsuitable for this clinical studies assessed by researcher.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intra-arterial cocktail therapy	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

Primary Outcome Measures

Name	Time	Method
Proportion of favorable outcome	90 days	favorable outcome is defined as mRS 0-2

Secondary Outcome Measures

Name	Time	Method
proportion of early neurological improvement	48 hours	early neurological improvement is defined as more than 4 decrease in NIHSS
Proportion of excellent outcome	90 days	excellent outcome is defined as mRS 0-1

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 ShenYang, China