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

Sponsor

Shanghai Yueyang Integrated Medicine Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05996978

Collaborator

(none)

Enrollment

Location

38.9

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	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 Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Feb 1, 2023

Actual Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Characteristics of the vessel wall [3 years]
The characteristics of the vessel wall were evaluated by high-resolution magnetic resonance imaging (HR-MRI).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine	Shanghai		China

Sponsors and Collaborators

Shanghai Yueyang Integrated Medicine Hospital

Investigators

Study Chair: Yan Han, M.D., Shanghai University of Traditional Chinese Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Yueyang Integrated Medicine Hospital

ClinicalTrials.gov Identifier:

NCT05996978

Other Study ID Numbers:

No.2019-112

First Posted:

Aug 18, 2023

Last Update Posted:

Aug 18, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2023