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NCT Number: NCT04202549

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Northern Theater Command

Shenyang, 110840, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Proportion of favorable outcome

    Time frame: 90 days

    favorable outcome is defined as mRS 0-2

Secondary outcomes

  1. Proportion of excellent outcome

    Time frame: 90 days

    excellent outcome is defined as mRS 0-1

  2. proportion of early neurological improvement

    Time frame: 48 hours

    early neurological improvement is defined as more than 4 decrease in NIHSS

Other outcomes

  1. incidence of symptomatic intracranial haemorrhage

    Time frame: 48 hours

    intracranial haemorrhage is defined as more than 4 increase in NIHSS caused by intracranial bleeding

Sponsors and collaborators

Lead sponsor

Hui-Sheng Chen

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2019
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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