Ischemic StrokeNCT05620615
Intensive Drug Therapy for Ischemic Stroke
An observational study of Ischemic Stroke, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Intensive Drug Therapy
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute stroke caused by intracranial arterial stenosis (stenosis rate ≥70%)
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai
Jia Zhou, M.D., pdzhoujia@163.com
About this study
Official title: 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 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).
Read the 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 the Ethics Committee of Huashan Hospital.
- Conditions
- Ischemic Stroke
- Being tested
- Intensive Drug Therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Drug TherapyOther
Also called observational only ,no intervention
Observational only and no predesigned interventions in this study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intensive Drug Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (2)
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.
Measured: 90 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Jul 2018
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Han, M.D., Study chair, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620615
- Sponsor's protocol ID
- No.2011-260
- Status last verified
- Dec 2022
- First submitted
- 10 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Drug Therapy for Ischemic Stroke Caused by Severe Intracranial Arterial Stenosis
- ClinicalTrials.gov ID
- NCT05620615
- Acronym / sponsor ID
- No.2011-260
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 the Ethics Committee of Huashan Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive Drug Therapy | – | Other: Intensive Drug TherapyDual 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute stroke caused by intracranial arterial stenosis (stenosis rate ≥70%)
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Drug TherapyAlso: observational only ,no interventionObservational only and no predesigned interventions in this study | Other | Intensive Drug Therapy |
Primary outcome
Percentage of patients with the 3-month new vascular events
Time frame: 90 days
Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke
2 secondary outcomes
Modified Rankin Scale score (mRS) changes
Time frame: 90 days
The change of the National Institute of Health Stroke Scale (NIHSS) score
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Han, M.D. study chair
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huihui Lv, M.D. (+8613381655365, celeste-lvhh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with the 3-month new vascular events (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.