Intensive Drug Therapy for Ischemic Stroke

NCT05620615 | Unknown

• 1 other identifier: No.2011-260
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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

  90 days

Secondary Outcomes (2)

• Modified Rankin Scale score (mRS) changes

  90 days

• The change of the National Institute of Health Stroke Scale (NIHSS) score

  90 days

Study Arms (1)

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

Interventions

Intensive Drug Therapy OTHER

Observational only and no predesigned interventions in this study

Also known as: observational only ,no intervention

Intensive Drug Therapy

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (1)

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

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yan Han, M.D.

  Shanghai University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Huihui Lv, M.D.

CONTACT

+8613381655365; celeste-lvhh@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 17, 2022
• Study Start: July 1, 2018
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)