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

To observe the safety and efficacy of intensive drug therapy for ischemic stroke caused by severe intracranial arterial stenosis.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).

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Other: Intensive Drug Therapy

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 Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with acute stroke caused by intracranial arterial stenosis (stenosis rate ≥70%)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Intensive Drug Therapy; Observational only and no predesigned interventions in this study; Other Names: observational only ,no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of the vessel wall	The characteristics of the vessel wall were evaluated by high-resolution magnetic resonance imaging (HR-MRI).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of the serum LDL-C level	Low-density lipoprotein cholesterol (LDL-C) was tested in the laboratory before and after the treatment.	24 hours,14 days

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital
• Investigators: Study Chair: Yan Han, M.D., Shanghai University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: No.2019-112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No