Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
Drug Eluting Stent implantation: 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.
Aggressive medical treatment: 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).
Risk factor management: Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
Standard medical treatment: 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).
Study summary
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.
Eligibility
Primary outcome measure(s)
- 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. — 12 months after enrollment
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. - Severe or moderate bleeding (GUSTO score) — 12 months after enrollment
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
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Daxing District People's Hospital | Beijing | Beijing Municipality | Recruiting |
| Hejian People's Hospital | Cangzhou | Hebei | Recruiting |
| North China University of Science and Technology Affiliated Hospital | Tangshan | Hebei | Recruiting |
| Xingtai City Third Hospital | Xingtai | Hebei | Recruiting |
| General Hospital of The Yangtze River Shipping | Wuhan | Hubei | Recruiting |
| Baotou Central Hospital | Baotou | Inner Mongolia | Recruiting |
| Inner Mongolia Autonomous Region People's Hospital | Hohhot | Inner Mongolia | Recruiting |
| Tongliao City Hospital | Tongliao | Inner Mongolia | Recruiting |
| Wuhai People's Hospital | Wuhai | Inner Mongolia | Recruiting |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | Recruiting |
| The Second Norman Bethune Hospital of JilinUniversity, | Changchun | Jilin | Recruiting |
| General Hospital of Benxi Iron and Steel Co | Benxi | Liaoning | Recruiting |
| Shanxi Cardiovascular Hospital | Taiyuan | Shanxi | Recruiting |
| Shanxi Provincial People's Hospital | Taiyuan | Shanxi | Recruiting |
| The First Affiliated Hospital of College of Medicine | Hangzhou | Zhejiang | Recruiting |
| Lishui People's Hospital | Lishui | Zhejiang | Recruiting |
| Beilun People's Hospital of Ningbo City | Ningbo | Zhejiang | Recruiting |
More Beijing Tiantan Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04948749 on ClinicalTrials.gov ↗ ← All trials in China