An observational study in Ischemic Stroke, sponsored by Shanghai Yueyang Integrated Medicine Hospital. Status unknown at 1 site in China. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Shanghai Yueyang Integrated Medicine Hospital · Observational
To observe the safety and efficacy of intensive drug therapy for ischemic stroke patients.Patients with acute stroke caused by intracranial arterial stenosis (stenosis rate ≥70%) were enrolled and accept dual antiplatelet therapy (DAPT) (aspirin 100 mg/d and clopidogrel 75 mg/d for 90 days, followed by aspirin 100 mg/d for long term) under the guidance of platelet function analysis (Verifynow) combined with the intensive statin therapy (40 mg/d for 14 days, followed by 20 mg/d for long term).
Patients (35 to 80 years ) with acute ischemic stroke, who can be treated within 72 hours of symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomly selected.Patients were treated with dual antiplatelet therapy (DAPT) (aspirin 100 mg per day and clopidogrel 75 mg per day were administered for 90 days, followed by aspirin 100 mg per day for long term) and atorvastatin (40 mg per day for 14 days, followed by 20 mg per day long term) after enrollment. Patients with aspirin resistance (aspirin reaction units [ARU] ≥550) or clopidogrel resistance (P2Y12 reaction units [PRU] ≥208) were excluded on the 7th day of therapy.The primary objective is to observe the safety and efficacy of intensive drug therapy for ischemic stroke patients. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by the Ethics Committee of Huashan Hospital.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 42 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Shanghai Yueyang Integrated Medicine Hospital is the lead sponsor of 35 studies on the registry; 14 are open to participants now.
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Patients with acute stroke caused by intracranial arterial stenosis (stenosis rate ≥70%)
Exclusion Criteria:
Dual antiplatelet therapy (DAPT) (aspirin 100 mg per day and clopidogrel 75 mg per day were administered for 90 days, followed by aspirin 100 mg per day for long term) and atorvastatin (40 mg per day for 14 days, followed by 20 mg per day long term) after enrollment.
Other: Intensive Drug Therapy
Observational only and no predesigned interventions in this study
Also known as: observational only ,no intervention
Percentage of patients with the 3-month new vascular events
Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke
Time frame: 90 days
Modified Rankin Scale score (mRS) changes
Assess patients' prognosis by the score of modified Rankin Scale (mRS). In the mRS, the lowest score is 0, the highest score is 6, and higher scores mean worse outcome. A score of 0 indicates the patients have no symptoms at all, and a score of 6 indicates the patients are dead. In this study, we evaluate patient's outcomes by the following criteria. A favorable outcome is defined as an mRS score of 0 to 2, an excellent outcome is defined as an mRS score of 0 to 1, whereas a poor outcome is defined as mRS\>2.
Time frame: 90 days
The change of the National Institute of Health Stroke Scale (NIHSS) score
The percentage of functional recovery or deterioration from baseline to 7 days after stroke onset, is measured by the National Institute of Health Stroke Scale, short for NIHSS. NIHSS score from 0-42, higher scores mean worse outcome. We define early functional improvement as an improvement of ≥ 4 points on the NIHSS or the resolution of the neurologic deficit, and early neurological deterioration as a decline by ≥ 4 points in the total NIHSS score within 7 days of symptom onset.
Time frame: 90 days
Plan to share: No
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This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Yueyang Integrated Medicine Hospital