NCT05620615

Intensive Drug Therapy for Ischemic Stroke

Intensive Drug Therapy for Ischemic Stroke Caused by Severe Intracranial Arterial Stenosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 42 (estimated)
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
OTHER	Intensive Drug Therapy	Observational only and no predesigned interventions in this study

Timeline

• Start date: 2018-07-01
• Primary completion: 2023-04-01
• Completion: 2023-12-01
• First posted: 2022-11-17
• Last updated: 2022-12-07

Locations

1 site across 1 country: China