Acute Ischemic StrokePhase 3NCT06113848
Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy
A Phase 3 study testing Intra-Arterial TNK and Albumin, Intra-Arterial TNK and Intra-Arterial Albumin in people with Acute Ischemic Stroke, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the feasibility and efficacy of intra-arterial TNK and albumin for patients with acute ischemic stroke after successful thrombectomy and whether there is a synergistic effect between TNK and albumin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intra-Arterial TNK and Albumin, Intra-Arterial TNK and Intra-Arterial Albumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2023to 7 Sep 2024
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AIS patients with large vessel occlusion;
- Age between 18 and 80 years;
- Baseline NIHSS score ≥ 6; 4 .Successful recanalization after thrombectomy (mTICI grades ≥ 2b);
- 5. ASPECTS score ≥ 6 on CT; 6. First episode or previous episode without significant sequelae (mRS ≤ 2); 7. Time from onset to femoral artery puncture ≤ 24 hours; 8. Written informed consent provided by the patients or their legal relatives.
Who cannot join
- Upon admission, the patient's medical history and physical examination revealed manifestations indicative of congestive heart failure (CHF), such as jugular venous distention, the presence of a third heart sound, resting tachycardia at a rate of 100 beats per minute attributable to heart failure, hepatomegaly, and/or lower extremity edema attributable to heart failure or of unknown etiology;
- History of acute myocardial infarction within the preceding 3 months;
- The patient's medical history, electrocardiogram findings upon admission, or physical examination indicated the presence of second- or third-degree heart block or any arrhythmia associated with hemodynamic instability, as determined by the investigator's assessment;
- Acute or chronic renal failure with serum creatinine levels exceeding 2.0 mg/dL;
- Severe anemia characterized by a hematocrit below 32%;
- Computed tomography findings upon admission indicating the presence of any form of hemorrhage;
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- Pregnancy status;
- Previous history of allergic reactions to albumin administration or TNK administration;
- Elevated blood pressure exceeding 185/110 mmHg when investigating the use of albumin administration or TNK administration;
- Presence of other potentially life-threatening medical conditions;
- Individuals with current chronic lung diseases, such as chronic obstructive pulmonary disease, bronchiectasis, or any other lung disorder that significantly impairs daily activities;
- Individuals with known allergies to albumin or TNK;
- Patients with reocclusion within 24 hours;
- Clinical suspicion of aortic coarctation、 bacterial embolism and infective endocarditis;
- Patients with a history of coagulation disorders and systemic bleeding tendencies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300222
Ming Wei, PhD, 13502182903, drweiming@163.com
Ming Wei, PhD
About this study
Official title: Feasibility and Efficacy of Intra- Arterial TNK and Albumin as an Adjunct to Thrombectomy for Acute Stroke
The purpose of this study is to investigate the feasibility and efficacy of intra-arterial TNK and albumin for patients with acute ischemic stroke after successful thrombectomy and whether there is a synergistic effect between TNK and albumin.
Read the detailed description
Endovascular therapy is the first-line treatment for acute ischemic stroke with large vessel occlusion. However, many studies have shown that, even with successful recanalization, about half of patients do not achieve functional independence. This phenomenon is called futile recanalization, which is partly attributed to brain no-reflow (microcirculation reperfusion failure despite recanalization of the occluded large artery). The mechanisms of brain no-reflow phenomenon include inflammation, micro thrombosis, aggregation platelets and red blood cells, and pericyte contraction.
Albumin, the most copious plasma protein synthesized primarily in the liver, possesses various biochemical properties, including anti-inflammatory, inhibiting platelet aggregation and micro thrombosis formation, and increasing microvascular perfusion. All of these properties are directed toward the mechanisms of no-reflow production, so albumin may inhibit no-reflow to improve the prognosis of stroke patients. TNK is a new generation thrombolytic agent that inhibits thrombosis, improves microcirculatory perfusion, and may inhibit no-reflow. These functions of TNK are similar to those of albumin, and the two also can reduce infraction volume and cerebral edema, and improve of behavioral function. In this study, we plan to determine the feasibility and efficacy of intra-arterial TNK and albumin for stroke patients undergoing successful mechanical thrombectomy and whether there is a synergistic effect between TNK and albumin.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intra-Arterial TNK and Albumin, Intra-Arterial TNK, Intra-Arterial Albumin, sham
- Keywords
- Acute ischemic stroke, Albumin, TNK, No-reflow, Endovascular Therapy, Large Vessel Occlusion
- 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 TNK and AlbuminDrug
The study population was divided into four groups, one of which had intra-arterial TNK and albumin.
Intra-Arterial TNKDrug
The study population was divided into four groups, one of which had intra-arterial TNK .
Intra-Arterial AlbuminDrug
The study population was divided into four groups, one of which had intra-arterial albumin.
shamOther
The study population was divided into four groups, one of which had no intra-arterial TNK and albumin.
| Study group | Role | What they receive |
|---|---|---|
| Intra-Arterial TNK and Albumin | Active comparator | Not described Receives: Drug: Intra-Arterial TNK and Albumin |
| Intra-Arterial TNK | Active comparator | Not described Receives: Drug: Intra-Arterial TNK |
| Intra-Arterial Albumin | Active comparator | Not described Receives: Drug: Intra-Arterial Albumin |
| sham | Sham comparator | Not described Receives: Other: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with major response
Major response is any of the following:
- Any forms of intracranial hemorrhage;
- Pulmonary edema;
- Heart failure;
- Skin itching, dyspnea and other allergic reactions;
- Death of any causes.
Measured: 7 days after initiation of TNK or albumin intra-arterially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start7 Sep 2023
- Primary completion7 Sep 2024 (estimated)
- Study completion7 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113848
- Sponsor's protocol ID
- TJHH-2023-wm16
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Intra- Arterial TNK and Albumin as an Adjunct to Thrombectomy for Acute Stroke
- ClinicalTrials.gov ID
- NCT06113848
- Acronym / sponsor ID
- TJHH-2023-wm16
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Albumin, TNK, No-reflow, Endovascular Therapy, Large Vessel Occlusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 7 Sep 2024 (estimated)
- Study completion
- 7 Sep 2024 (estimated)
- First posted
- 2 Nov 2023 (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.
The purpose of this study is to investigate the feasibility and efficacy of intra-arterial TNK and albumin for patients with acute ischemic stroke after successful thrombectomy and whether there is a synergistic effect between TNK and albumin.
Detailed description
Endovascular therapy is the first-line treatment for acute ischemic stroke with large vessel occlusion. However, many studies have shown that, even with successful recanalization, about half of patients do not achieve functional independence. This phenomenon is called futile recanalization, which is partly attributed to brain no-reflow (microcirculation reperfusion failure despite recanalization of the occluded large artery). The mechanisms of brain no-reflow phenomenon include inflammation, micro thrombosis, aggregation platelets and red blood cells, and pericyte contraction.
Albumin, the most copious plasma protein synthesized primarily in the liver, possesses various biochemical properties, including anti-inflammatory, inhibiting platelet aggregation and micro thrombosis formation, and increasing microvascular perfusion. All of these properties are directed toward the mechanisms of no-reflow production, so albumin may inhibit no-reflow to improve the prognosis of stroke patients. TNK is a new generation thrombolytic agent that inhibits thrombosis, improves microcirculatory perfusion, and may inhibit no-reflow. These functions of TNK are similar to those of albumin, and the two also can reduce infraction volume and cerebral edema, and improve of behavioral function. In this study, we plan to determine the feasibility and efficacy of intra-arterial TNK and albumin for stroke patients undergoing successful mechanical thrombectomy and whether there is a synergistic effect between TNK and albumin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intra-Arterial TNK and Albumin | Active comparator | Drug: Intra-Arterial TNK and Albumin |
| Intra-Arterial TNK | Active comparator | Drug: Intra-Arterial TNK |
| Intra-Arterial Albumin | Active comparator | Drug: Intra-Arterial Albumin |
| sham | Sham comparator | Other: sham |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AIS patients with large vessel occlusion;
- Age between 18 and 80 years;
- Baseline NIHSS score ≥ 6; 4 .Successful recanalization after thrombectomy (mTICI grades ≥ 2b);
- 5. ASPECTS score ≥ 6 on CT; 6. First episode or previous episode without significant sequelae (mRS ≤ 2); 7. Time from onset to femoral artery puncture ≤ 24 hours; 8. Written informed consent provided by the patients or their legal relatives.
Key exclusion criteria (15 listed)
- Upon admission, the patient's medical history and physical examination revealed manifestations indicative of congestive heart failure (CHF), such as jugular venous distention, the presence of a third heart sound, resting tachycardia at a rate of 100 beats per minute attributable to heart failure, hepatomegaly, and/or lower extremity edema attributable to heart failure or of unknown etiology;
- History of acute myocardial infarction within the preceding 3 months;
- The patient's medical history, electrocardiogram findings upon admission, or physical examination indicated the presence of second- or third-degree heart block or any arrhythmia associated with hemodynamic instability, as determined by the investigator's assessment;
- Acute or chronic renal failure with serum creatinine levels exceeding 2.0 mg/dL;
- Severe anemia characterized by a hematocrit below 32%;
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 TNK and AlbuminThe study population was divided into four groups, one of which had intra-arterial TNK and albumin. | Drug | Intra-Arterial TNK and Albumin |
| Intra-Arterial TNKThe study population was divided into four groups, one of which had intra-arterial TNK . | Drug | Intra-Arterial TNK |
| Intra-Arterial AlbuminThe study population was divided into four groups, one of which had intra-arterial albumin. | Drug | Intra-Arterial Albumin |
| shamThe study population was divided into four groups, one of which had no intra-arterial TNK and albumin. | Other | sham |
Primary outcome
Number of participants with major response
Time frame: 7 days after initiation of TNK or albumin intra-arterially
Major response is any of the following: 1. Any forms of intracranial hemorrhage; 2. Pulmonary edema; 3. Heart failure; 4. Skin itching, dyspnea and other allergic reactions; 5. Death of any causes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra-Arterial TNK and Albumin, Intra-Arterial TNK and Intra-Arterial Albumin in people with Acute Ischemic Stroke, run by Tianjin Huanhu Hospital 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 15 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: status not confirmed, as of the sponsor's last update on 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with major response (time frame: 7 days after initiation of TNK or albumin intra-arterially). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2023.