Intensive Drug Therapy for Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620615
• Other study ID #: No.2011-260
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2022
• Source: Shanghai Yueyang Integrated Medicine Hospital
• Contact: Huihui Lv, M.D.
• Phone: +8613381655365
• Email: celeste-lvhh[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Intensive Drug Therapy
Observational only and no predesigned interventions in this study

Locations

Country	Name	City	State
China	Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Yueyang Integrated Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Modified Rankin Scale score (mRS) changes	Assess patients' prognosis by the score of modified Rankin Scale (mRS). In the mRS, the lowest score is 0, the highest score is 6, and higher scores mean worse outcome. A score of 0 indicates the patients have no symptoms at all, and a score of 6 indicates the patients are dead. In this study, we evaluate patient's outcomes by the following criteria. A favorable outcome is defined as an mRS score of 0 to 2, an excellent outcome is defined as an mRS score of 0 to 1, whereas a poor outcome is defined as mRS>2.	90 days
Secondary	The change of the National Institute of Health Stroke Scale (NIHSS) score	The percentage of functional recovery or deterioration from baseline to 7 days after stroke onset, is measured by the National Institute of Health Stroke Scale, short for NIHSS. NIHSS score from 0-42, higher scores mean worse outcome. We define early functional improvement as an improvement of = 4 points on the NIHSS or the resolution of the neurologic deficit, and early neurological deterioration as a decline by = 4 points in the total NIHSS score within 7 days of symptom onset.	90 days