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The aim of DREAM-PRIDE is to evaluate whether implantation of drug-eluting stent (DES) combined with aggressive medical treatment is more efficacious in prevention of 1-year stroke recurrence than standard medical treatment alone for symptomatic intracranial atherosclerotic disease.
This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent combined with aggressive medical treatment versus standard medical treatment to treat symptomatic intracranial atherosclerotic disease. Primary efficacy endpoints (any of the following): 1) any stroke or death within 30 days after enrollment, 2) any stroke or death within 30 days after a revascularization procedure of the qualifying lesion during follow-up, 3) ischemic stroke in the territory of the qualifying artery beyond 30 days to 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting stent implantation with aggressive medical treatment group | Experimental | DES implantation (The Maurora ® Sirolimus Eluting Stent System) combined with aggressive medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 6 months); management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise) |
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| Standard medical treatment group | Active Comparator | Standard medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 3 months after enrolment), management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Eluting Stent implantation | Device | The Maurora ® Sirolimus Eluting Stent System for intracranial PTA treatment comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end. |
| Measure | Description | Time Frame |
|---|---|---|
| Any stroke or death within 30 days of enrollment or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year. | Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year. Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery. Symptomatic brain hemorrhage is defined as parenchymal, subarachnoid, or intraventricular hemorrhage detected by CT or MRI that is associated with new neurological signs or symptoms (headache, change in level of consciousness, focal neurological symptoms) lasting ≥ 24 hours or a seizure. | 12 months after enrollment |
| Severe or moderate bleeding (GUSTO score) | Bleeding events were defined according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification for severe or life-threatening, moderate, or mild bleeding: Severe or life-threatening- Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate- Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild- Bleeding that does not meet criteria for either severe/life-threatening or moderate bleeding | 12 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Residual stenosis after the procedure in DES group | Degree of residual stenosis was measured and calculated according to the methods of the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial. | At the end of the procedure |
| In-stent restenosis (ISR) rate in DES group within 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Ma, MD | Contact | 13581889908 | maning_03@hotmail.com | |
| Baixue Jia, MD | Contact | 15010125093 | beckyberry@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang, MD | Beijing Tiantan Hospital | Principal Investigator |
| Zhongrong Miao, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31248666 | Background | Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24. | |
| 30871944 |
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Parallel Assignment
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| Aggressive medical treatment | Drug | Aggressive medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 6 months after enrollment). |
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| Risk factor management | Behavioral | Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise) |
|
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| Standard medical treatment | Drug | Standard medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 3 months after enrollment). |
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The ISR is defined as >50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss. |
| 12 months after enrollment |
| Disabling stroke within 1 year | defined as modified Rankin Scale > 3 at 1 year visit | 12 months after enrollment |
| Any stroke, death or myocardial infarction within 1 year | Any stroke included ischemic stroke and symptomatic brain hemorrhage. Symptomatic brain hemorrhage refers to parenchymal, subarachnoid, or intraventricular hemorrhage that was associated with a seizure or with symptoms or signs lasting 24 hours or longer. | 12 months after enrollment |
| Major non-stroke hemorrhage within 1 year | A major non-stroke-related hemorrhage was defined as any subdural or epidural hemorrhage or a systemic hemorrhage requiring hospitalization, blood transfusion, or surgery. | 12 months after enrollment |
| Modified Rankin Scale score at 1 year | The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome. | 12 months after enrollment |
| Death within 1 year | Death within 1 year | 12 months after enrollment |
| Beijing Daxing District People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Hejian People's Hospital | Recruiting | Cangzhou | Hebei | China |
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| North China University of Science and Technology Affiliated Hospital | Recruiting | Tangshan | Hebei | China |
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| Xingtai City Third Hospital | Recruiting | Xingtai | Hebei | China |
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| General Hospital of The Yangtze River Shipping | Recruiting | Wuhan | Hubei | China |
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| Baotou Central Hospital | Recruiting | Baotou | Inner Mongolia | China |
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| Inner Mongolia Autonomous Region People's Hospital | Recruiting | Hohhot | Inner Mongolia | China |
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| Tongliao City Hospital | Recruiting | Tongliao | Inner Mongolia | China |
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| Wuhai People's Hospital | Recruiting | Wuhai | Inner Mongolia | China |
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| The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
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| The Second Norman Bethune Hospital of JilinUniversity, | Recruiting | Changchun | Jilin | China |
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| General Hospital of Benxi Iron and Steel Co | Recruiting | Benxi | Liaoning | China |
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| Shanxi Cardiovascular Hospital | Recruiting | Taiyuan | Shanxi | China |
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| Shanxi Provincial People's Hospital | Recruiting | Taiyuan | Shanxi | China |
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| The First Affiliated Hospital of College of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| Lishui People's Hospital | Recruiting | Lishui | Zhejiang | China |
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| Beilun People's Hospital of Ningbo City | Recruiting | Ningbo | Zhejiang | China |
|
| Background |
| GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11. |
| 15800226 | Background | Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033. |
| 21899409 | Background | Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7. |
| 23277374 | Background | Shin YS, Kim BM, Suh SH, Jeon P, Kim DJ, Kim DI, Kim BS, Kim KH, Heo JH, Nam HS, Kim YD. Wingspan stenting for intracranial atherosclerotic stenosis: clinical outcomes and risk factors for in-stent restenosis. Neurosurgery. 2013 Apr;72(4):596-604; discussion 604. doi: 10.1227/NEU.0b013e3182846e09. |
| 23963335 | Background | Jin M, Fu X, Wei Y, Du B, Xu XT, Jiang WJ. Higher risk of recurrent ischemic events in patients with intracranial in-stent restenosis. Stroke. 2013 Nov;44(11):2990-4. doi: 10.1161/STROKEAHA.113.001824. Epub 2013 Aug 20. |
| 29102578 | Background | Lu WD, Huang CW, Li YH, Chen JY. Multiple Mechanisms in 1 In-Stent Restenosis Assessed by Optical Coherence Tomography. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2340-2341. doi: 10.1016/j.jcin.2017.07.017. Epub 2017 Nov 1. No abstract available. |
| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012307 | Risk Factors |
| ID | Term |
|---|---|
| D012306 | Risk |
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D015984 | Causality |
| D015981 | Epidemiologic Factors |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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