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

NCT ID: NCT04202549

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-15
• Study Completion Date: 2022-09-20

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

intra-arterial cocktail therapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hui-Sheng Chen

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

References

Zhao ZA, Hu HZ, Li W, Qiu J, Zhao YG, Nguyen TN, Chen HS. Intra-arterial cocktail therapy for patients with anterior circulation large vessel occlusion who achieved endovascular reperfusion. Front Neurol. 2024 Dec 6;15:1450156. doi: 10.3389/fneur.2024.1450156. eCollection 2024.

Reference Type: DERIVED

PMID: 39711792 (View on PubMed)

Other Identifiers

k(2019)31

Identifier Type: -

Identifier Source: org_study_id