Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II
- Conditions
- Transient Ischemic AttackStroke
- Interventions
- Registration Number
- NCT04078737
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
The primary objective of this trial is to assess the effects of ticagrelor plus aspirin versus clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke.
- Detailed Description
According to the Global Burden of Disease(GBD) Study 2016, China bears the greatest lifetime risk of stroke from 25-year-age onward. Minor ischemic events, including minor stroke and TIA, were major parts of stroke manifestations. Events (CHANCE) has shown that 21-day dual antiplatelet therapy (clopidogrel and aspirin) compared to aspirin alone which initiated within 24 hours after symptoms onset would reduce 32% risk of stroke recurrence within 90 day, but not in carriers of CYP2C19 loss-of-function (LOF) alleles. The primary purpose of this study is to compare ticagrelor plus aspirin with clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke.
Both intent analysis (ITT) and compliance program set (PPS) were used for analysis.
We will use Kaplan-Meier estimates of the cumulative risk of stroke (ischemic or hemorrhagic) event during maximum 90-day follow-up, with hazards ratios and 95% CI calculated using Cox proportional hazards methods and the log-rank test to evaluate the treatment effect. All statistics will be 2-sided with P\<0.05 considered significant, accounting for interim analyses.
All patients who received study drugs and with at least one safety follow-up record will be included in the safety population. The data for safety evaluation included adverse reactions observed during the trial and changes in laboratory data before and after treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6412
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ticagrelor plus Aspirin Group Ticagrelor and Aspirin Ticagrelor of loading dosing of 180mg followed by 90mg bid for 3 months plus aspirin of loading dose of 75-300mg followed by 75mg daily for 21 days Clopidogrel plus Aspirin Group Clopidogrel and Aspirin Clopidogrel of loading dosing of 300mg followed by 75mg daily for 3 months plus aspirin loading dose of 75-300mg followed by 75mg daily for 21 days
- Primary Outcome Measures
Name Time Method Any new stroke events (ischemic stroke or hemorrhagic stroke) within 3 months 3 months after randomization The aim is to assess the effects of ticagrelor plus aspirin versus clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke.
- Secondary Outcome Measures
Name Time Method Any new stroke events within 30 days and 1 year 30 days and 1 year after randomization Percentage of patients with the 30 days and 1 year new stroke events (ischemic stroke/ hemorrhagic stroke) as a cluster and evaluated individually.
New clinical vascular events including stroke, TIA, myocardial infarction, and vascular deaths within 3 months and 1 year 3 months and 1 year after randomization Percentage of patients with the 3 months and 1 year new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death)
New ischemic stroke within 3 months and 1 year 3 months and 1 year after randomization Percentage of patients with the 3 months and 1 year new ischemic stroke will be evaluated.
Incidence and severity of recurrent stroke and TIA during follow-up to 3 months and 1-year 3 months and 1 year after randomization (Severity is measured using a six-level ordered categorical scale that incorporates the mRS: fatal stroke/severe non-fatal stroke \[mRS 4 or 5\]/moderate stroke \[mRS 2 or 3\]/mild stroke \[mRS 0 or 1\]/TIA/no stroke-TIA).
Disabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year 3 months and 1 year after randomization Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS scores between 3 to 6 points are considered to be poor functional outcome. (dead).
Neurological impairment at 3 months (NIHSS increased≥4 from baseline) 3 months after randomization The National Institutes of Health Stroke Scale (NIHSS) score classifies neurologic deficit from 0 (no deficit) to 42 (most severe).
Quality of Life (EuroQol EQ-5D scale) at 3 months and at 1 year 3 months and 1 year after randomization Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale). We will use the EQ-5D-5L scale to evaluate the quality of life. EQ-5D-5L is a standardized instrument for measuring generic health status. It has been widely used in population health surveys, clinical studies, economic evaluation and in routine outcome measurement in the delivery of operational healthcare. The EQ-5D-5L has five domain scales (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and five levels for each domain.
Stratified analysis 3 months and 1 year after randomization The influence on treatment effect of age, gender, Body Mass Index (BMI), index event type (TIA vs. minor stroke), time from index event to randomization, etiology subtype, diabetes mellitus, hypertension, type of LOF allele, previous ischemic stroke or TIA, prior antiplatelet therapy, prior statin therapy, prior smoking status, and symptomatic intracranial and extracranial artery stenosis will be evaluated in subgroup analyses.
Trial Locations
- Locations (214)
Anqing Municipal Hospital
🇨🇳Anqing, Anhui, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Beijing Chaoyang Hospital, Capital MedicalUniversity（west Hospital）
🇨🇳Beijing, Beijing, China
Beijing Tian tan Hospital
🇨🇳Beijing, Beijing, China
Beijing Shunyi Airport Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of Fangshan District
🇨🇳Beijing, Beijing, China
Beijing Coal Group Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Chongqing People's Hospital
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Scroll for more (204 remaining)Anqing Municipal Hospital🇨🇳Anqing, Anhui, China