Back to resultsImproving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Intra-arterial Cocktail Therapy (INSIST-CT)
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intra-arterial cocktail therapy
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
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.
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.
Sites / Locations
- General Hospital of Northern Theater CommandRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intra-arterial cocktail therapy
Arm 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
Outcomes
Primary Outcome Measures
Proportion of favorable outcome
favorable outcome is defined as mRS 0-2
Secondary Outcome Measures
Proportion of excellent outcome
excellent outcome is defined as mRS 0-1
proportion of early neurological improvement
early neurological improvement is defined as more than 4 decrease in NIHSS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04202549
Brief Title
Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Intra-arterial Cocktail Therapy (INSIST-CT)
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hui-Sheng Chen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intra-arterial cocktail therapy
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
intra-arterial cocktail therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Proportion of favorable outcome
Description
favorable outcome is defined as mRS 0-2
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Proportion of excellent outcome
Description
excellent outcome is defined as mRS 0-1
Time Frame
90 days
Title
proportion of early neurological improvement
Description
early neurological improvement is defined as more than 4 decrease in NIHSS
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
incidence of symptomatic intracranial haemorrhage
Description
intracranial haemorrhage is defined as more than 4 increase in NIHSS caused by intracranial bleeding
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zi-Ai Zhao, Doctor
Phone
+86 17790998175
Email
zhaoziai@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Tao, Master
Phone
+86 18802401698
Email
1939908868@qq.com
Facility Information:
Facility Name
General Hospital of Northern Theater Command
City
ShenYang
ZIP/Postal Code
110840
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zi-Ai Zhao
12. IPD Sharing Statement
Learn more about this trial
Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Intra-arterial Cocktail Therapy (INSIST-CT)
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