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

NCT04202549 | Completed DMC

• 1 other identifier: k(2019)31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of favorable outcome

  favorable outcome is defined as mRS 0-2

  90 days

Secondary Outcomes (2)

• Proportion of excellent outcome

  90 days

• proportion of early neurological improvement

  48 hours

Other Outcomes (1)

• incidence of symptomatic intracranial haemorrhage

  48 hours

Study Arms (1)

intra-arterial cocktail therapy

EXPERIMENTAL

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

Drug: intra-arterial cocktail therapy

Interventions

intra-arterial cocktail therapy 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.

intra-arterial cocktail therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy.
• Sufficient recanalization （TICI 2b-3）within 7 hours of stroke onset.
• The availability of informed consent.

You may not qualify if:

• insufficient recanalization（TICI \< 2a）after endovascular treatment;
• Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage.
• \. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<100000/mm3）.
• \. 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.
• \. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).
• \. Patients with contraindication or allergic to any ingredient of drugs in our study.
• \. Unsuitable for this clinical studies assessed by researcher.

Sponsors & Collaborators

• Hui-Sheng Chen: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

Location

Related Publications (1)

• 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.

  PMID: 39711792 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 17, 2019
• Study Start: December 15, 2019
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

CN (1)