Status:
COMPLETED
Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
Stroke
Transient Ischemic Attack
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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, prima...
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 p...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 40 years or older than 40 years；
- Acute cerebral ischemic event due to：
- Acute non-disabling ischemic stroke (NIHSS≤3 at the time of randomization)or，
- TIA with moderate-to-high risk of stroke (ABCD2 score ≥ 4 at the time of randomization)；
- Can be treated with study drug within 24 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle)；
- CYP2C19 loss-of-function allele carriers；
- Informed consent signed.
- Exclusion Criteria
- Malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
- Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI.
- Iatrogenic causes (angioplasty or surgery) of minor stroke or TIA.
- Preceding moderate or severe dependency (modified Rankin scale \[mRS\] score 3-5).
- Contraindication to clopidogrel, ticagrelor or aspirin
- Known allergy
- Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST \> twice the upper limit of normal range) insufficiency
- Severe cardiac failure (NYHA level: III to IV)
- History of hemostatic disorder or systemic bleeding
- History of thrombocytopenia or neutropenia
- History of drug-induced hematologic disorder or hepatic dysfunction
- Low white blood cell (\<2×109/L) or platelet count (\<100×109/L)
- Hematocrit (HCT) \<30%
- Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)
- History of intracranial hemorrhage or amyloid angiopathy
- History of aneurysm (including intracranial aneurysm and peripheral aneurysm)
- History of asthma or COPD (chronic obstructive pulmonary disease)
- High-risk for bradyarrhythmia (first-degree or second-degree AV block caused by sinus node disease, and brady-arrhythmic syncope without pacemaker)
- History of hyperuricemia nephropathy
- Anticipated requirement for long-term (\>7 days) non-steroidal anti-inflammatory drugs (NSAIDs)
- Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
- Scheduled for surgery or interventional treatment requiring study drug cessation
- Severe non-cardiovascular comorbidity with life expectancy \< 3 months
- Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders
- Dual antiplatelet treatment (or more than two antiplatelet agents) in 72 hours before randomization
- Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation
- Intravenous thrombolytic therapy (such as intravenous rtPA) or mechanical thrombectomy within 24 hours prior to randomization
- Gastrointestinal bleed within 3 months or major surgery within 30 days
- Diagnosis or suspicious diagnosis of acute coronary syndrome
- Participation in another clinical study with an experimental product during the last 30 days
- Currently receiving an experimental drug or device
- Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control
Exclusion
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
6412 Patients enrolled
Trial Details
Trial ID
NCT04078737
Start Date
September 23 2019
End Date
July 1 2021
Last Update
December 2 2021
Active Locations (214)
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1
Anqing Municipal Hospital
Anqing, Anhui, China, 246003
2
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
3
Beijing Chaoyang Hospital, Capital MedicalUniversity（west Hospital）
Beijing, Beijing Municipality, China, 100043
4
Beijing Tian tan Hospital
Beijing, Beijing Municipality, China, 100070