Endovascular Treatment for Acute Large Vessel Occlusion With Ultra-Large Ischemic Core (LARGE CORE-MT)
Endovascular Treatment for Acute Large Vessel Occlusion With Ultra-Large Ischemic Core: A Prospective, Multicenter, Randomized, Open-label, Blinded Endpoint Trial (LARGE CORE-MT)
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The primary objective is to determine whether EVT combined with BMM, compared with BMM alone, improves functional outcome in patients with intracranial LVO in anterior circulation and ultra large-core treated within 24 hours of symptom onset.
Primary Efficacy Endpoint Analysis The primary efficacy endpoint is the mRS score at 90 days after randomization. The proportional odds assumption will be formally assessed. If this assumption holds (score test p-value > 0.05), the primary effect measure is the common odds ratio (cOR), which will be estimated using an ordinal logistic regression model to assess the shift in the overall distribution of the mRS scale at 90 days. The model will be adjusted for known prognostic factors including baseline ASPECTS score, age, NIHSS score at admission, and intravenous thrombolysis, as well as the randomization stratification factor, i.e., time from stroke onset or last known well to randomization (≤6 hours vs. >6 hours). Unadjusted cOR estimates and confidence intervals (CI) will also be reported. If the assumption is violated, the generalized odds ratio (GenOR) and its 95% CI will be derived as a robust alternative measure of treatment effect.
Secondary Efficacy Endpoints Analysis For the secondary endpoint of mRS score at 180 days after randomization, the same analysis method as for the primary endpoint will be used. For the proportions of mRS 0-2 and mRS 0-3 at 90 days and 180 days, early neurological improvement, a modified Poisson regression model will be used, reporting Risk Ratio and 95% CI, with the same adjustment factors as in the primary endpoint analysis. For the comparison of EQ-5D-5L score at 90 days between two arms, a linear regression model will be used to estimate the mean difference and 95% CI. For the change in infarct volume from baseline assessed by NCCT at 7 (±1) days or discharge (whichever occurs earlier), or by MRI at 36 (±12) hours after randomization, a linear regression model will be used to estimate the mean difference and 95% CI, with treatment group as the study variable and baseline measurement as a covariate; if normality assumptions are violated, the win ratio method will be used.
Safety Analysis For the primary safety endpoint of all-cause mortality within 90 days after randomization, the Chi-squared test or Fisher's exact test will be used for between-group comparison. For the secondary safety endpoints, including incidence of sICH within 24 hours from onset, proportion of early neurological deterioration, procedure- or device-related complications, and serious adverse events adjudicated by the Clinical Events Committee, data summary will be performed by treatment group.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Guang Zhang, MD, PhD
- 전화번호: +86 451 85555099
- 이메일: zhangguang@hrbmu.edu.cn
연구 장소
-
-
Hei Longjiang
-
Harbin, Hei Longjiang, 중국, 150001
- he First Affiliated Hospital of Harbin Medical University
-
연락하다:
- Guang Zhang, M.D., Ph.D.
- 전화번호: +86 451 85555099
- 이메일: zhangguang@hrbmu.edu.cn
-
수석 연구원:
- Huaizhang SHi, M.D., Ph.D.
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- ≥18 years.
- Symptoms onset or Time last known well ≤ 24 h from randomization.
- Acute ischemic stroke due to an occlusion of the intracranial internal carotid artery, M1 or proximal M2 segment of the middle cerebral artery confirmed by CTA or MRA.
- NCCT or diffusion-weighted imaging (DWI) demonstrating ASPECTS ≤ 2 or infarct core volume (defined as rCBF <30% on CTP) ≥ 100 mL.
- Selection imaging performed ≤ 3 hours before randomization.
- Pre-stroke mRS 0 - 1.
- Informed consent form was signed.
Exclusion Criteria:
- Evidence of intracranial hemorrhage on CT/MRI, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, or subdural/epidural hemorrhage.
- Cerebral midline shift or herniation, or other ventricular mass effect with midline shift as confirmed on CT/MRI.
- Bilateral anterior circulation or acute multi-vessel occlusion involving both anterior and posterior circulation, confirmed by CTA or MRA.
- Blood pressure >185/110 mmHg and is refractory to medicine.
- Known coagulopathy, with international normalized ratio (INR) >1.7 or platelet count <100×10⁹/L;
- Current treatment with direct thrombin inhibitors or factor Xa inhibitors;
- Patients with severe organ failure (cardiac, pulmonary, renal, or hepatic);
- Concomitant malignancy or other conditions with life expectancy under 6 months;
- Female who is known to be pregnant;
- Prior endovascular attempt for this stroke;;
- Currently participation in another clinical study;
- Other circumstances that the investigator considers inappropriate for participation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: EVT group
|
EVT should be performed as soon as possible in patients randomized to the EVT group.
Investigators and clinicians should make every effort to minimize delays related to pre-procedural preparation, with a target interval of no more than 60 minutes from randomization to arterial puncture.
EVT in the EVT group can be performed with any thrombectomy device (NMPA approved) usually used at study site.
|
|
활성 비교기: Medical group
|
The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to current AIS management guidelines but may NOT include any intra-arterial therapies.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
The primary efficacy endpoint is the mRS score at 90 days after randomization.
기간: at 90 days after randomization.
|
at 90 days after randomization.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
mRS score at 180 days after randomization.
기간: at 180 days after randomization.
|
at 180 days after randomization.
|
|
Proportion of mRS 0-2 at 90 days and 180 days after randomization.
기간: at 90 days and 180 days after randomization.
|
at 90 days and 180 days after randomization.
|
|
Proportion of mRS 0-3 at 90 days and 180 days after randomization.
기간: at 90 days and 180 days after randomization.
|
at 90 days and 180 days after randomization.
|
|
Proportion of early neurological improvement
기간: at day 7 (±1) or discharge (whichever is earlier).
|
at day 7 (±1) or discharge (whichever is earlier).
|
|
Infarct volume change from baseline NCCT at 7 (±1) days after randomization or discharge (whichever is earlier), or by MRI at 36 (±12) hours.
기간: at 7 (±1) days after randomization or discharge (whichever is earlier), or by MRI at 36 (±12) hours.
|
at 7 (±1) days after randomization or discharge (whichever is earlier), or by MRI at 36 (±12) hours.
|
|
EQ-5D-5L score at 90 days.
기간: at 90 days.
|
at 90 days.
|
기타 결과 측정
기타 결과 측정
결과 측정 |
기간 |
|---|---|
|
Incidence of all-cause mortality within 90 days after randomization.
기간: within 90 days after randomization.
|
within 90 days after randomization.
|
|
Incidence of symptomatic intracranial hemorrhage (sICH, per Heidelberg Bleeding Classification) at 24±12 hours from onset.
기간: at 24±12 hours from onset.
|
at 24±12 hours from onset.
|
|
Incidence of early neurological deterioration
기간: defined as a NIHSS increase ≥ 10 points at day 7 (±1) or discharge (whichever is earlier). Death within 7 days of onset is directly judged as neurological deterioration.
|
defined as a NIHSS increase ≥ 10 points at day 7 (±1) or discharge (whichever is earlier). Death within 7 days of onset is directly judged as neurological deterioration.
|
|
Procedure- or device-related complications
기간: perioperative period
|
perioperative period
|
|
Serious adverse events (SAE) adjudicated by the Clinical Events Committee.
기간: within 180 days after randomization
|
within 180 days after randomization
|
공동 작업자 및 조사자
스폰서
스폰서
수사관
수사관
- 수석 연구원: Huaizhang Shi, MD, PhD, The First Affiliated Hospital of Harbin Medical University, China
- 수석 연구원: Wei Hu, MD, PhD, The First Affiliated Hospital of USTC (Anhui Provincial Hospital), China
- 수석 연구원: Jianmin Liu, MD, PhD, Changhai Hospital, China
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- LARGE CORE-MT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
- The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered.
- The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials.
- Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research.
- Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection.
- The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .