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

Hui-Sheng Chen

Status: Completed

Conditions: Ischemic Stroke

Treatments: Drug: intra-arterial cocktail therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04202549

k(2019)31

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

intra-arterial cocktail therapy

Experimental group

Description:

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

Treatment:

Drug: intra-arterial cocktail therapy