- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02506140
Platelet Reactivity in Acute Non-disabling Cerebrovascular Events (PRINCE)
July 22, 2020 updated by: Yongjun Wang, Beijing Tiantan Hospital
A Randomized, Open-label, Active-Controlled and Blinded-Endpoint Trial Comparing the Antiplatelet Effects of Ticagrelor Plus Aspirin Versus Clopidogrel Plus Aspirin in Chinese Patients With High-risk Transient Ischemic Attack or Minor Stroke.
Ticagrelor is a reversible and direct-acting oral antagonist of the P2Y12 (Purinergic receptor P2Y, G-protein coupled, 12) receptor for adenosine diphosphate, which provides faster, greater, and more consistent P2Y12 inhibition than Clopidogrel in patients with acute coronary syndrome, irrespective of the genetic variants affecting Clopidogrel metabolism.
It is still undefined whether combination therapy of Ticagrelor and Aspirin is more effective than Clopidogrel and aspirin for minor stroke and transient ischemic attack (TIA).
The primary purpose of the PRINCE trial is to evaluate the anti-platelet effects of a 3-month regimen of ticagrelor initiated with 180 mg loading dose followed by 90 mg twice/day combined with aspirin 100 mg/day during first 21 days versus a 3-month regimen of clopidogrel initiated with 300 mg loading dose of followed by 75 mg/day combined with aspirin 100 mg/day during first 21 days when initiated within 24 hours of symptom onset in high-risk transient ischemic attack or minor stroke.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The PRINCE trial is a prospective, randomized, multi-centre, open-label, active-controlled, blinded-endpoint trial (a PROBE design concerning clinical trial).
A total of approximately 952 patients (40years≤Age<80years) with high-risk TIA (defined as an ABCD2 score ≥ 4 or the stenosis of offending vessel ≥ 50%) or minor ischemic stroke (defined as an NIHSS ≤ 3), who can be treated within 24 hours of symptom onset will be enrolled.
Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive a 180 mg loading dose of ticagrelor on the day of randomization, followed by 90 mg twice/day ticagrelor from Day 2 to 3 months; 2) the other group will receive a 300 mg loading dose of clopidogrel on the day of randomization, followed by 75 mg once/day clopidogrel from Day 2 to 3 months.
Aspirin will be given in a total dose of 100-300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 21 in the both groups.
The primary objective is to assess the anti-platelet effects of Ticagrelor combined with Aspirin versus Clopidogrel combined with Aspirin in Chinese patients with high-risk TIA and minor stroke.
The study consists of six visits including the day of randomization, 2 hours after the first anti-platelet agents, 24 hours after the first anti-platelet agents, Day 7+2days, Day 21±2days and Day 90±7days.
Genomic DNA of all patients will be collected for genotyped.
And the genetic variants affecting Clopidogrel metabolism will be analyzed.
The antiplatelet effects will be analyzed in total subjects and genetic variants carriers.
The trial is anticipated to complete in 18 months from the first subject recruitment , with 952 subjects recruited from 25 centres in China.
A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study.
The trial has been approved by IRB(Institutional Review Board) /EC(Ethics Committee) in Beijing Tiantan hospital, Capital Medical University.
Study Type
Interventional
Enrollment (Actual)
675
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100012
- Aviation General Hospital of China Medical University
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Beijing, China, 100050
- Beijing Tian Tan Hospital, Capital Medical University
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Beijing, China, 100078
- Dongfang Hospital Beijing University of Chinese Medicine
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Beijing, China, 102400
- The First Hospital of Fangshan District,Beijing
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Chongqing, China, 400042
- Daping Hospital,Third Military Medical University
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Shanghai, China, 200127
- Renji Hospital,Shanghai Jiao Tong University School of Medicine
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Tianjin, China, 300350
- Tianjin Huanhu Hospital
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Fujian
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Fuzhou, Fujian, China, 350005
- The First Affiliated Hospital Of Fujian Medical University
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Guangdong
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Shenzhen, Guangdong, China, 518000
- The second people's hospital of Shenzhen
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Hebei
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Shijiazhuang, Hebei, China, 050000
- The Second Hospital of Hebei Medical University
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Tangshan, Hebei, China, 063000
- Tangshan Gongren Hospital
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Tangshan, Hebei, China, 063000
- North China University of Science and Technology Affiliated Hospital
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Henan
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Zhengzhou, Henan, China, 450052
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, China, 430060
- Renmin Hospital of Wuhan University
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Wuhan, Hubei, China, 430022
- Union Hospital,Tongji Medical College,Huazhong University of Science and Technology
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Wuhan, Hubei, China, 430022
- Wuhan No.1 hospital
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Wuhan, Hubei, China, 430014
- Wuhan Brain Hospital,General Hospital of The Yangtze River Shipping
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Hunan
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Changsha, Hunan, China, 410008
- Xiangya Hospital Central South University
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Jiangsu
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Yangzhou, Jiangsu, China, 225001
- Northern Jiangsu People's Hospital,Clinical Medical School,YangZhou University
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Liaoning
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Shengyang, Liaoning, China, 110016
- General Hospital of Shenyang Military
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Shanxi
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Taiyuan, Shanxi, China, 030001
- The Second Hospital of Shanxi Medical University
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Taiyuan, Shanxi, China, 030003
- General Hospital of TISCO
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Zhejiang
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Taizhou, Zhejiang, China, 318020
- Taizhou First People's Hospital,Huangyan Hospital of Wenzhou Medical University
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Wenzhou, Zhejiang, China, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Wenzhou, Zhejiang, China, 325000
- Wenzhou Hospital of integrated Chinese and Western medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of informed consent.
- Female or male aged≥ 40 years and <80 years.
- Acute non-disabling ischemic stroke (NIHSS≤ 3 at the time of randomization) that can be treated with study drug within 24 hours of symptoms onset defined by the"last see normal"principle.
- TIA (Neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with study drug within 24 hours of symptoms onset and with moderate-to-high risk of stroke recurrence (ABCD2 score ≥ 4 at the time of randomization or the stenosis of offending vessel ≥ 50%).
Exclusion Criteria:
- Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head Computed Tomography (CT) or magnetic resonance imaging (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.
- Modified Rankin Scale Score > 2 at randomization (pre-morbid historical assessment)。
Contraindication to ticagrelor, clopidogrel or acetylsalicylic acid :
- Known hypersensitivity
- Severe renal or hepatic insufficiency
- Severe cardiac failure, asthma
- Hemostatic disorder or systemic bleeding
- History of hemostatic disorder or systemic bleeding
- History of drug-induced hematologic or hepatic abnormalities
- Low white blood cell (<2 x10^9/L) or platelet count (<100 x10^9/L)
- Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, ventricular aneurysm, prosthetic cardiac valves known, suspected endocarditis or other suspicion of cardioembolic pathology for TIA/stroke).
- Continuous use of ticagrelor or clopidogrel over 5 days before randomization
- Current treatment (last dose given within 10 days before randomization) with heparin therapy or anti coagulation therapy (e.g., warfarin; thrombin inhibitors such as dabigatran , argatroban, bivalirudin, ximelagatran; factor Xa inhibitors such as rivaroxaban, edoxaban, apixaban, betrixaban, tanexaban ; hirudin; unfractionated and low molecular weight heparins ).
- Receipt of intravenous/ intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomization.
- History of intracranial hemorrhage or cerebral artery amyloidosis.
- History of aneurysm (including intracranial aneurysm or peripheral aneurysms)
- Diagnosis or of acute coronary syndrome.
- History of asthma or COPD (chronic obstructive pulmonary disease).
- High risk of bradyarrhythmia, such as sick sinus syndrome second-degree or third-degree atrioventricular block, bradycardia-related syncope without installed pacemaker.
- History of uric acid nephropathy.
- Anticipated requirement for long-term (>7 days) non-study anti-platelet drugs, or NSAIDs (nonsteroidal antiinflammatory drugs) affecting platelet function.
- History of previous symptomatic non-traumatic intracerebral bleed at any time (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past 3 months, or major surgery within 30 days.
- Qualifying TIA or minor stroke induced by angiography or surgery.
- Planned or likely revascularization within the next 3 months.
- Scheduled for surgery or interventional treatment requiring study drug cessation.
- Severe non-cardiovascular comorbidity with life expectancy < 3 months.
- Pregnancy or lactation, and women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test.
- Currently receiving an investigational drug or device.
- Participation in another clinical study with an investigational product during the last 30 days.
- Inability of the patient to understand and/or comply with study procedures and/or follow-up, in the opinion of the Investigator.
- Hematocrit (Hct) < 30%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Ticagrelor/ASA
Drugs: Ticagrelor and Acetylsalicylic acid.
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This group will receive a 180 mg loading dose of ticagrelor on the day of randomization, followed by 90 mg twice/day ticagrelor from Day 2 to 3 months; combined with Aspirin given in a total dose of 100-300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 21.
Other Names:
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ACTIVE_COMPARATOR: Clopidogrel/ASA
Drugs: Clopidogrel and Acetylsalicylic acid.
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This group will receive a 300 mg loading dose of clopidogrel on the day of randomization, followed by 75 mg once/day clopidogrel from Day 2 to 3 months; combined with Aspirin given in a total dose of 100-300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 21.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
High on-treatment platelet reactivity (HOPR) defined as P2Y12 reaction unit (PRU)> 208 measured by VerifyNow® assay at 90 days
Time Frame: 90 days
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90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HOPR at 90 days in subjects carrying genetic variants which affected Clopidogrel metabolism.
Time Frame: 90 days
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HOPR defined as P2Y12 reaction unit (PRU)> 208 measured by VerifyNow® assay
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90 days
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New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage).
Time Frame: 90 days, 6 months, 1 year
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All the new vascular events will be assessed by at least two neurologists based on neuroimaging and clinical feature.
When there was disagreement, a third senior neurologist was consulted to reach a consensus decision.
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90 days, 6 months, 1 year
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New composite clinical vascular events (ischemic stroke/ hemorrhagic stroke/TIA/ myocardial infarction/ vascular death) as a cluster.
Time Frame: 90 days, 6 months, 1 year
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All the new composite clinical vascular events will be assessed by at least two neurologists based on laboratory examination, imaging and clinical feature.
When there was disagreement, a third senior neurologist was consulted to reach a consensus decision.
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90 days, 6 months, 1 year
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High on-treatment platelet reactivity defined as PRU> 208 measured by VerifyNow® assay.
Time Frame: 2hours, 24 hours, 7 days
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2hours, 24 hours, 7 days
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High on-treatment platelet reactivity defined as Aspirin reactivity unit (ARU)> 555 measured by VerifyNow® assay.
Time Frame: 7 days
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7 days
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HOPR defined as Maximum Amplitude-adenosine diphosphate (MA-ADP)>47 measured by Thrombelastography Platelet Mapping Assay (TEG) using the inducer of adenosine diphosphate.
Time Frame: 90 days
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90 days
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Residual platelet reactivity defined as the value of PRU.
Time Frame: 2hours, 24 hours, 7 days, 90 days
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2hours, 24 hours, 7 days, 90 days
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Residual platelet reactivity defined as the value of Aspirin reaction unit (ARU).
Time Frame: 7days
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7days
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Residual platelet reactivity defined as the value of MA-ADP.
Time Frame: 7days, 90 days
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7days, 90 days
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Residual platelet reactivity defined as the value of Maximum Amplitude- acetylsalicylic acid (MA-AA) measured by TEG.
Time Frame: 7days
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7days
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Residual platelet reactivity change from baseline in PRU.
Time Frame: 2hours, 24 hours, 7 days, 90 days
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2hours, 24 hours, 7 days, 90 days
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Residual platelet reactivity change from baseline in ARU.
Time Frame: 7 days
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7 days
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The inhibition of platelet aggregation (IPA) measured by VerifyNow® assay.
Time Frame: 2hours, 24 hours, 7 days, 90 days
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2hours, 24 hours, 7 days, 90 days
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The TEG-platelet inhibition(TPI)measured by TEG.
Time Frame: 7 days, 90 days
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7 days, 90 days
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Platelet inhibition change from baseline in IPA.
Time Frame: 2hours, 24 hours, 7 days, 90 days
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2hours, 24 hours, 7 days, 90 days
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Platelet inhibition change from baseline in TPI.
Time Frame: 7 days, 90 days
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7 days, 90 days
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Residual platelet reactivity detected by AspirinWorks.
Time Frame: 7days
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7days
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Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®).
Time Frame: 7days, 90days
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7days, 90days
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Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6.
Time Frame: 90 days, 6 months, 1 year
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90 days, 6 months, 1 year
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Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 90 days, 6 months, 1 year follow-up)
Time Frame: 90 days, 6 months, 1 year
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90 days, 6 months, 1 year
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Further efficacy exploratory analysis:Quality of Life (The EuroQol-5D 3 level version[EQ-5D-3L]scale).
Time Frame: 90 days, 6 months, 1 year
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90 days, 6 months, 1 year
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Major bleed (PLATO definition), including fatal/life-threatening and other.
Time Frame: 90 days, 6 months, 1 year
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The PLATO(Platelet Inhibition and Patient Outcomes) definition of fatal/life-threatening of major bleed is any one of the following: Fatal, Intracranial, Intrapericardial bleed with cardiac tamponade, Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery, Clinically overt or apparent bleeding associated with a decrease in hemoglobin(Hb) of more than50 g/L, Transfusion of 4 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding.
The PLATO definition of other of major bleed is any one of the following:Significantly disabling (eg.
intraocular with permanent vision loss), Clinically overt or apparent bleeding associated with a decrease in Hb of 30 g/L to 50 g/L, Transfusion of 2-3 units (whole blood or PRBCs) for bleeding.
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90 days, 6 months, 1 year
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Intracranial hemorrhagic events.
Time Frame: 90 days, 6 months, 1 year
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Intracranial hemorrhagic events is assessed by brain computed tomography (CT) or gradient recalled echo (GRE) T2 star weighted MRI.
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90 days, 6 months, 1 year
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Total mortality.
Time Frame: 90 days, 6 months, 1 year
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All deaths reported post-randomization will be recorded and adjudicated.
Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular.
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90 days, 6 months, 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yang Y, Chen W, Pan Y, Yan H, Meng X, Liu L, Wang Y, Wang Y. Ticagrelor Is Superior to Clopidogrel in Inhibiting Platelet Reactivity in Patients With Minor Stroke or TIA. Front Neurol. 2020 Jun 10;11:534. doi: 10.3389/fneur.2020.00534. eCollection 2020.
- Yang Y, Chen W, Meng X, Liu L, Wang Y, Pan Y, Wang Y. Impact of smoking on platelet function of ticagrelor versus clopidogrel in minor stroke or transient ischaemic attack. Eur J Neurol. 2020 May;27(5):833-840. doi: 10.1111/ene.14171. Epub 2020 Mar 8.
- Wang Y, Chen W, Lin Y, Meng X, Chen G, Wang Z, Wu J, Wang D, Li J, Cao Y, Xu Y, Zhang G, Li X, Pan Y, Li H, Zhao X, Liu L, Lin J, Dong K, Jing J, Johnston SC, Wang D, Wang Y; PRINCE Protocol Steering Group. Ticagrelor plus aspirin versus clopidogrel plus aspirin for platelet reactivity in patients with minor stroke or transient ischaemic attack: open label, blinded endpoint, randomised controlled phase II trial. BMJ. 2019 Jun 6;365:l2211. doi: 10.1136/bmj.l2211.
- Wang Y, Lin Y, Meng X, Chen W, Chen G, Wang Z, Wu J, Wang D, Li J, Cao Y, Xu Y, Zhang G, Li X, Pan Y, Li H, Liu L, Zhao X, Wang Y; PRINCE Protocol Steering Group. Effect of ticagrelor with clopidogrel on high on-treatment platelet reactivity in acute stroke or transient ischemic attack (PRINCE) trial: Rationale and design. Int J Stroke. 2017 Apr;12(3):321-325. doi: 10.1177/1747493017694390. Epub 2017 Jan 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (ACTUAL)
March 1, 2017
Study Completion (ACTUAL)
March 1, 2018
Study Registration Dates
First Submitted
July 19, 2015
First Submitted That Met QC Criteria
July 22, 2015
First Posted (ESTIMATE)
July 23, 2015
Study Record Updates
Last Update Posted (ACTUAL)
July 24, 2020
Last Update Submitted That Met QC Criteria
July 22, 2020
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Stroke
- Ischemia
- Ischemic Attack, Transient
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Ticagrelor
- Clopidogrel
Other Study ID Numbers
- D151100002015001
- 81322019 (OTHER_GRANT: National Natural Science Foundation of China)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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