Thrombolysis and RIPC in Acute Ischemic Stroke (tripcais)
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|ClinicalTrials.gov Identifier: NCT03218293|
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke, Cerebral Embolism and Thrombosis||Device: RIPC device (IPC-906X)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Recovery of Nerve Function Deficient of Combined Intravenous Thrombolysis and Remote Ischemic Post-conditioning in Acute Ischemic Stroke.|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Remote ischemic postconditioning（RIPC）：Patients in the RIPC group not only receive foundational treatment but also have five cycles of 5‑min cuff inflation followed by 3‑min deflation to the bilateral upper arm using a RIPC device (IPC-906X; Beijing Renqiao Institute of Neuroscience, Beijing, China) after thrombolysis while in-hospital.
Device: RIPC device (IPC-906X)
Patients in the RIPC group had five cycles of 5‑min cuff inflation followed by 3‑min deflation to the bilateral upper arm after thrombolysis.
Other Name: Thrombolysis
No Intervention: Blank control group(BC)
Blank control group:Patients in the BC group only receive foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin, 100-300 mg/d) and lipid-lowering (atorvastatin, 20 mg/d) drugs,throughout the 14 days in-hospital period without remote ischemic postconditioning after thrombolysis.
- vascular endothelial growth factor (VEGF), pg/ml [ Time Frame: From date of randomization until the date of 14 days and 3 months or date of death from any cause, whichever came first, assessed up to 12 months ]
- basic fibroblast growth factor (bFGF),pg/ml [ Time Frame: From date of randomization until the date of 14 days and 3 months or date of death from any cause, whichever came first, assessed up to 12 months ]
- Change from baseline National Institute of Health stroke scale at 14 days, scores. [ Time Frame: 14 days ]
- Change from baseline Activities of Daily Living at 3 months, scores. [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218293
|Contact: Guogang Luo, firstname.lastname@example.org|
|Contact: Jiaqi An, email@example.com|
|The First Affiliated Hospital of Xi'an Jiaotong University||Recruiting|
|Xi'an, China, 710061|
|Contact: Guogang Luo, Ph.D. 86-13991974085|