Ischemic StrokeNCT04202549
Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Intra-arterial Cocktail Therapy (INSIST-CT)
A study testing intra-arterial cocktail therapy in people with Ischemic Stroke, run by Hui-Sheng Chen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- intra-arterial cocktail therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2019to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- intra-arterial cocktail therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-arterial cocktail therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: intra-arterial cocktail therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of favorable outcome
favorable outcome is defined as mRS 0-2
Measured: 90 days
Secondary outcomes (2)
Proportion of excellent outcome
excellent outcome is defined as mRS 0-1
Measured: 90 days
proportion of early neurological improvement
early neurological improvement is defined as more than 4 decrease in NIHSS
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start15 Dec 2019
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui-Sheng Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202549
- Sponsor's protocol ID
- k(2019)31
- Status last verified
- Nov 2023
- First submitted
- 15 Dec 2019
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39711792
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04202549
- Acronym / sponsor ID
- k(2019)31
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hui-Sheng ChenUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intra-arterial cocktail therapy | Experimental | Drug: intra-arterial cocktail therapyIntra-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-arterial cocktail therapyIntra-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 |
Primary outcome
Proportion of favorable outcome
Time frame: 90 days
favorable outcome is defined as mRS 0-2
2 secondary outcomes
Proportion of excellent outcome
Time frame: 90 days
proportion of early neurological improvement
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 39711792Zhao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-arterial cocktail therapy in people with Ischemic Stroke, run by Hui-Sheng Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of favorable outcome (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023; AzTrials last refreshed its copy on 3 Nov 2026.