Intensive Drug Therapy for Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2023-12-01

Brief Summary

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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).

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Detailed Description

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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

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive Drug Therapy

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.

Intensive Drug Therapy

Intervention Type OTHER

Observational only and no predesigned interventions in this study

Interventions

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Intensive Drug Therapy

Observational only and no predesigned interventions in this study

Intervention Type OTHER

Other Intervention Names

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observational only ,no intervention

Eligibility Criteria

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Inclusion Criteria

* Age between 35 and 80 years;
* Onset \<72 hours;
* New-onset ischemic stroke confirmed by skull magnetic resonance diffusion weighted imaging (MR-DWI);
* Severe ICAS (stenosis ≥70%) indicated by time-of-flight magnetic resonance angiography (TOF-MRA).

Exclusion Criteria

* Ischemic stroke caused by other etiological factors (e.g., cardio-embolism, arterial dissection, vasculitis, etc.);
* Post-infarction hemorrhagic transformation and intraplaque hemorrhage as indicated by imaging examination;
* Contraindications to aspirin, clopidogrel, or atorvastatin;
* Intracranial hemorrhage within 3 months and a recent history of surgery or trauma;
* Severe organ impairment, liver insufficiency, and renal insufficiency;
* Complicated with tumors or hemorrhagic diseases;
* Use of drugs forbidden to use in combination after onset, including other antiplatelet drugs, anticoagulants, thrombolytic drugs, and drugs affecting antiplatelet agents and statin metabolism.

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No