- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04551664
Study of Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core (ANGEL-ASPECT)
Study of Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core: A Multi-centered, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial(ANGEL-ASPECT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100010
- Beijing TianTan Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
General Inclusion Criteria
- 18 to 80 years of age
- Presenting with symptoms consistent with an AIS
- Pre-stroke mRS score 0-1
- NIHSS score 6-30 at the time of randomization
- Randomization can be finished within 24 hours of stroke onset (stroke onset time is defined as last known well time)
- Informed consent signed Specific Neuroimaging Inclusion Criteria
- CTA or MRA proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery
Combination of NCCT ASPECTS and perfusion core volume when ASPECTS <3 or > 5 (6h-24h). Imaging evidence of low ASPECTS (based on NCCT) or large infarct Core (defined as rCBF <30% on CT perfusion or ADC<620 on MRI) filling one of the following criteria:
- ASPECTS 3-5
- ASPECTS >5 (6h-24h) with infarct core volume 70-100 ml
- ASPECTS <3 with infarct core volume 70-100 ml
Exclusion Criteria:
General Exclusion Criteria
- Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test;
- Known severe allergy (more than a rash) to contrast media uncontrolled by medications;
- Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg);
- Known hemorrhagic tendency (including but not limited to): Baseline platelet count <100×109/L; Heparin was administered within 48 hours with APTT≥35s; on anticoagulant therapy with warfarin and International Normalized Ratio (INR) > 1.7 (Patients with no history or suspected coagulopathy do not need to wait for laboratory results of INR or APTT prior to enrollment)
- Parenchymal organ surgery and biopsy were performed in the past one month
- Any active bleeding or recent bleeding (gastrointestinal bleeding, urinary bleeding, etc.) in the past one month
- Undergoing hemodialysis or peritoneal dialysis; Known severe renal insufficiency with glomerular filtration rate <30 ml/min or serum creatinine >220 mmol/L (2.5mg/dl)
- Brain tumor (with mass effect)
- The expected survival time is less than 1 year (such as complicated with malignant tumor, serious heart and lung diseases, etc.)
- Participation in other interventional randomized clinical trials that may confound outcome assessment of the trial
- Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders)
Specific Neuroimaging Exclusion Criteria
- Midline shift, herniation or mass effect with effacement of the ventricles
- Evidence of acute intracranial hemorrhage
- Acute bilateral strokes or multiple intracranial vessels occlusions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: EVT group
Patients in this group will receive best medical management plus EVT including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting.
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All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.
In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice.
Mechanical thrombectomy (recommended with Solitaire、EMBOTRAP、Trevo or Reco revascularization device) or aspiration thrombectomy (recommended with Penumbra) will be recommended as the primary treatment.
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Active Comparator: Best medical management group
Patients in this group will receive best medical management alone.
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All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurofunctional deficit defined as modified Rankin Scale (mRS)
Time Frame: 90±7 days after randomization
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The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead |
90±7 days after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard
Time Frame: within 48 hours after randomization
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Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below:
Absence of alternative explanation for deterioration. |
within 48 hours after randomization
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90-day good clinical outcome
Time Frame: 90±14 days after randomization
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Good clinical outcome defined as a dichotomized mRS 0-2 outcome
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90±14 days after randomization
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90-day favorable clinical outcome
Time Frame: 90±7 days after randomization
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Favorable clinical outcome defined as a dichotomized mRS 0-3 outcome
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90±7 days after randomization
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Dramatic recovery
Time Frame: baseline, 36±12 hours after randomization
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36-hour (24-48 hours) NIHSS score ≤1 or ≥10 points drop as compared with baseline
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baseline, 36±12 hours after randomization
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Change of infarct volume from baseline to 36-hour (24-48 hours)
Time Frame: baseline, 36±12 hours after randomization
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The infarct volume is determined on a diffusion-weighted MRI map based on an ADC threshold of less than 620 ×10-6mm2/s or on CTP image with rCBF<30%
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baseline, 36±12 hours after randomization
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All-cause mortality rate
Time Frame: 90±7 days after randomization
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All-cause mortality rate at 90±14 days
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90±7 days after randomization
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Any type of intracranial hemorrhage according to Heidelberg Classification.
Time Frame: 36±12 hours after randomization
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Any type of intracranial hemorrhage according to Heidelberg Classification.
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36±12 hours after randomization
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Rate of decompressive hemicraniectomy
Time Frame: 7±1 days after randomization or discharge
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Rate of decompressive hemicraniectomy
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7±1 days after randomization or discharge
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Rate of successful recanalization
Time Frame: 36±12 hours after randomization
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Rate of participants with recanalization of the primary arterial occlusive lesion at 36±12 hours
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36±12 hours after randomization
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zhongrong Miao, MD, PhD, Beijing Tiantan Hospital, Capital Medical Univerity
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HX-A-011(2020)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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