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 : April 25, 2019
|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%) 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, and ADC), cranial magnetic resonance angiography (MRA), intracranial vessel wall imaging and susceptibility weighted imaging (SWI).
- Enrolled patients will receive aggressive medical management consisted of Aspirin (100 mg daily) and Clopidogrel (75 mg daily) for 3 months and Crestor (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 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 dynamic changes of intracranial plaque under aggressive medical management using new imaging package and establish a risk model to predict stroke recurrence and unfavorable outcome in patients with symptomatic intracranial stenosis.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 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%) who receive aggressive medical management
Drug: aggressive medical management
Aspirin (100 mg daily) and Clopidogrel (75 mg daily) for 3 months and Crestor (20mg daily) for at least 6 months as well as traditional risk factors management
- stroke recurrence [ Time Frame: 12 months after stroke onset ]stroke recurrence with new lesions on DWI
- modified Rankin Scale [ Time Frame: 12 months after stroke onset ]The scale 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 Death due to Heart Disease, Cerebravascular Disease or Other Vascular Etiology [ Time Frame: 3 months 6 months 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: 3 months, 6 months, 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: 3 months, 6 months, 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|
Show 33 Study Locations
|Study Chair:||Weihai Xu, MD||Peking Union Medical College Hospital|