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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05631847
Other study ID # GFQ18981838913
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 17, 2023
Est. completion date May 31, 2027

Study information

Verified date February 2024
Source Sichuan Academy of Medical Sciences
Contact Fu-Qiang Guo, M.D.
Phone +8618981838913
Email guofuqiang2005@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Two recent randomized controlled trials (BAOCHE and ATTENTION) have confirmed the efficacy and safety of endovascular therapy in patient with acute ischemic stroke (AIS) due to basilar artery occlusion (BAO). However, it is still inconclusive whether there is any differences between endovascular therapy with or without bridging intravenous thrombolysis in acute BAO. So far, no randomized controlled trial has been conducted specifically for endovascular therapy with or without intravenous thrombolysis for ischemic stroke due to BAO. Therefore, this study plans to conduct a prospective, multicenter, randomized controlled trial to compare the functional outcomes between endovascular therapy with and without intravenous thrombolysis in patient with AIS due to BAO. This study is a multicenter, parallel, open label, randomized controlled trial comparing direct endovascular therapy versus endovascular therapy bridging intravenous thrombolysis (IVT). This study intends to include patients with AIS due to BAO fulfilling the following inclusion criteria: patients with AIS caused by BAO confirmed by CTA/MRA/DSA; IVT can be started within 4.5 hours after symptoms onset; Age ≥ 18 years old; NIHSS score ≥ 6. The main outcome is the 3-month mRS scale score. Secondary outcomes included NIHSS at 24 hours and 7 days after surgery, CTA vascular recanalization at 24-72 hours, mRS at 5-7 days, and infarct volume. The safety outcomes included 90-day mortality and the incidence of sICH.


Recruitment information / eligibility

Status Recruiting
Enrollment 336
Est. completion date May 31, 2027
Est. primary completion date January 15, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - A clinical diagnosis of acute ischemic stroke (AIS); - Caused by basilar artery occlusion (BAO) confirmed by CTA, MRA, or DSA; - CT or MRI ruling out intracranial hemorrhage; - Eligible for intravenous thrombolysis (IVT) and endovascular treatment (EVT) (within 4.5 hours after symptom onset); - A score of at least 6 on the NIHSS score; - Age of 18 years or older; - Written informed consent. Exclusion Criteria: - Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2 - Any contra-indication for intravenous thrombolysis (IVT), according to guidelines of the American Heart Association, i.e.: - Arterial blood pressure exceeding 185/110 mmHg - Blood glucose less than 2.7 or over 22.2 mmol/L - Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging - Serious head trauma in the previous 3 months - Major surgery or serious trauma in the previous 2 weeks - Gastrointestinal or urinary tract hemorrhage in the previous 3 weeks - Previous intracerebral hemorrhage - Use of anticoagulant with INR exceeding 1.7 - Known thrombocyte count less than 100 x 10^9/L - Treatment with direct thrombin or factor X inhibitors - Treatment with heparin (APTT exceeds the upper limit of normal value) in the previous 48 hours.

Study Design


Intervention

Procedure:
Endovascular treatment
It is the emergency surgical removal of emboli which are blocking blood circulation. The strategies that were used for endovascular treatment included stent retrievers, thromboaspiration, balloon angioplasty, stent deployment, intraarterial thrombolysis (with alteplase), or combinations of these approaches that were left to the discretion of the treating team.
Drug:
Intravenous thrombolysis (Alteplase)
Alteplase is used in the intravenous thrombolysis. It catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for clot breakdown.

Locations

Country Name City State
China Bazhong Central Hospital Bazhong Sichuan
China Chengdu Third People's Hospital Chengde Sichuan
China Affiliated Hospital of Chengdu Medical College Chengdu Sichuan
China Chengdu Fifth People's Hospital Chengdu Sichuan
China Chengdu First People's Hospital Chengdu Sichuan
China Chengdu Second People's Hospital Chengdu Sichuan
China Chongzhou People's Hospital Chengdu Sichuan
China Dayi County People's Hospital Chengdu Sichuan
China Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital Chengdu Sichuan
China Western Theater General Hospital Chengdu Sichuan
China Banan Hospital Affiliated to Chongqing Medical University Chongqing Chongqing
China Chongqing Sanbo Chang'an Hospital Chongqing Chongqing
China Hechuan District People's Hospital Chongqing Chongqing
China Liangping District People's Hospital Chongqing Chongqing
China The First People's Hospital of Liangjiang New Area Chongqing Chongqing
China Yubei District People's Hospital Chongqing Chongqing
China Deyang People's Hospital Deyang Sichuan
China Guang'an Central Hospital Guang'an Sichuan
China Guangyuan Central Hospital Guangyuan Sichuan
China Guangyuan First People's Hospital Guangyuan Sichuan
China The Fifth People's Hospital Affiliated to Southern Medical University Guangzhou Guangdong
China The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) Hefei Anhui
China Qiandongnan Miao and Dong Autonomous Prefecture People's Hospital Kaili Guizhou
China Kashgar First People's Hospital Kashgar Xinjiang
China Affiliated Hospital of Southwest Medical University Luzhou Sichuan
China Mianyang 404 Hospital Mianyang Sichuan
China Mianyang Central Hospital Mianyang Sichuan
China Mianyang Third People's Hospital Mianyang Sichuan
China Affiliated Hospital of North Sichuan Medical College Nanchong Sichuan
China Langzhong People's Hospital Nanchong Sichuan
China Nanchong Central Hospital Nanchong Sichuan
China Yilong County People's Hospital Nanchong Sichuan
China Nanyang Central Hospital Nanyang Henan
China Neijiang Second People's Hospital Neijiang Sichuan
China Panzhihua Central Hospital Panzhihua Sichuan
China Suining Central Hospital Suining Sichuan
China Suining First People's Hospital Suining Sichuan
China Tongren People's Hospital Tongren Guizhou
China Qianxinan Buyei and Miao Autonomous Prefecture People's Hospital Xingyi Guizhou
China Ya'an People's Hospital Ya'an Sichuan
China Yibin First People's Hospital Yibin Sichuan
China Yibin Second People's Hospital Yibin Sichuan
China Zhuzhou Central Hospital Zhuzhou Hunan
China Zigong First People's Hospital Zigong Sichuan
China Zigong Third People's Hospital Zigong Sichuan
China Ziyang First People's Hospital Ziyang Sichuan

Sponsors (2)

Lead Sponsor Collaborator
Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary mRS (the modified Rankin Scale) score The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability. At 90 day after procedure
Secondary NIHSS (the National Institutes of Health Stroke Scale) score The NIHSS score is an ordinal hierarchical scale to evaluate the symptomatic severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores suggesting a more severe deficit. At 24 hours and 5-7 days after procedure
Secondary Recanalization rate The recanalization rate at 24-72 hours after endovascular treatment, assessed by computerized tomographic angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA). At 24-48 hours after endovascular treatment
Secondary Final infarct volume The final infarct volume will be assessed with the use of an automated, validated algorithm based on magnetic resource imaging test. At 5-7 days after procedure
Secondary All-cause mortality The proportion of total deaths caused by various reasons in both arms At 90 days after procedure
Secondary eTICI (Extended Treatment In Cerebral Ischemia) score The eTICI is an ordinal hierarchical scale ranging from 0 to 3, with higher scores suggesting better antegrade reperfusion of the previously occluded target artery ischemic territory. Immediately after endovascular treatment
Secondary sICH (symptomatic intracranial hemorrhage) rate The sICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by =4 points than the value at baseline or the lowest value in the first 7 days or any hemorrhage leading to death. At 7 days after endovascular treatment
Secondary Comparison of mRS 0-1 and mRS 2-6 The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability. At 90 days after procedure
Secondary Comparison of mRS 0-2 and mRS 3-6 The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability. At 90 days after procedure
Secondary Comparison of mRS 0-3 and mRS 4-6 The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability. At 90 days after procedure
Secondary EQ-5D-5L (the European Quality of Life 5-Dimension 5-Level) score The EQ-5D-5L score is an ordinal hierarchical scale to evaluate the quality of life. Scores range from -0.39 to 1, with higher scores indicating a better quality of life. At 90 days after procedure
Secondary Barthel Index dichotomized as 0 to 94 The Barthel Index is an ordinal hierarchical scale to evaluate the daily activities. Scores range from 0 to 100. The Barthel Index will be dichotomized as 0 to 94 vs. 95 to 100, with a score of 95 to 100 indicating no interference with daily activities. At 90 days after procedure
Secondary Proportion of new cerebral infarction The proportion of the new cerebral infarction compared with the onset of symptoms evaluated with magnetic resource imaging test At 5-7 days after procedure
Secondary Incidence of pseudoaneurysm at puncture site The pseudoaneurysm at puncture site caused by various reasons is one of the important indicators reflecting puncture complications. At 5-7 days after procedure
Secondary Incidence of hematoma at puncture site The hematoma at puncture site caused by various reasons is one of the important indicators reflecting puncture complications. At 5-7 days after procedure
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