Stroke Imaging Package Study of Intracranial Atherosclerosis ( SIPS-ICAS ) (SIPS-ICAS)
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|ClinicalTrials.gov Identifier: NCT03719820|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment|
|Acute Ischemic Stroke AIS Intracranial Atherosclerosis ICAS||Drug: aggressive medical management|
- First-ever stroke patients attributed to intracranial artery stenosis (> 50% or occlusion) within 7 days after onset will be prospectively enrolled in our study and undergo new imaging technique package assessment at baseline.
- The imaging technique package includes conventional cranial MRI （T1,T2,T2 FLAIR,DWI), cranial magnetic resonance angiography (MRA),high-resolution magnetic resonance (HR-MRI) and susceptibility weighted imaging (SWI) or T2*-weighted imaging.
- Enrolled patients are recommended to receive aggressive medical management consisted of Aspirin (100 mg daily) and Clopidogrel (75 mg daily) for 3 months and Rosuvastatin (20mg daily) for at least 6 months as well as traditional risk factors management.
- Patients were followed up for mRS score, stroke recurrence, medication compliance and laboratory examination including blood routine tests, liver functions and creatine kinase et al at 3 months, 6 months and 12 months after stroke onset. Additionally, patients are required to retake new HRMRI imaging of brain at 6 months.Remote patient education by We-Chat will be performed.
- Our study aims to explore the stroke mechanisms of symptomatic intracranial atherosclerosis, the dynamic changes under aggressive medical treatment and their associations with clinical events using conventional MRI sequences plus HR-MRI.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||550 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Stroke Imaging Package Study of Intracranial Atherosclerosis|
|Actual Study Start Date :||November 14, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2021|
First-ever stroke patients attributed to intracranial artery stenosis (> 50% or occlusion) who receive aggressive medical management
Drug: aggressive medical management
Aspirin (100 mg daily) and Clopidogrel (75 mg daily) for 3 months and Rosuvastatin (20mg daily) for at least 6 months as well as traditional risk factors management
- poor functional outcome [ Time Frame: 90 day after stroke onset ]The Rankin Score runs from 0-6, running from perfect health without symptoms to death. mRS 0-2 are defined as favorable outcomes while mRS 3-6 as unfavorable outcomes.0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.
- Number of Participants with stroke recurrence [ Time Frame: 12 months after stroke onset ]stroke recurrence with new lesions on DWI
- Evolution of intracranial atherosclerosis burden [ Time Frame: 6 months after stroke onset ]Changes of plaque and thrombus volume on HR-MRI images at the admission and the follow-up
- Number of Participants with Death due to Heart Disease, Cerebravascular Disease or Other Vascular Etiology [ Time Frame: 12 months after stroke onset ]death due to stroke, intracranial hemorrhage,heart attack,heart failure, arrhythmia,pulmonary embolism,visceral hemorrhage or other vascular etiology
- Number of Participants with Adverse Events That Are Related to Anti-platelet Treatment [ Time Frame: 12 months after stroke onset ]intracranial bleeding confirmed by CT，fatal bleeding causing hemodynamic abnormalities needed blood tranfusion or surgical intervention
- Number of Participants with Adverse Events That Are Related to StatinTreatment [ Time Frame: 12 months after stroke onset ]more than 3-fold liver enzyme increase，rhabdomyolysis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719820
|Contact: Weihai Xu, MDemail@example.com|
|Contact: Yining Huang, MDfirstname.lastname@example.org|
|Study Chair:||Weihai Xu, MD||Peking Union Medical College Hospital|