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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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19 February 2018 |
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Main ID: |
ChiCTR1800014908 |
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Date of registration:
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2018-02-17 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison the efficacy and safety of ticagrelor and TEG-optimized clopidogrel on emergency PCI for patients with acute non-ST segment-elevation myocardial infarction
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Scientific title:
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Comparison the efficacy and safety of ticagrelor and TEG-optimized clopidogrel on emergency PCI for patients with acute non-ST segment-elevation myocardial infarction |
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Date of first enrolment:
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2018-04-02 |
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Target sample size:
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ticagrelor group:500;TEG-optimizaed clopidogrel group:500;intensive statin group:500;low-dose statin group:500; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=25434 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Jingjin Che
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Address:
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23 Pingjiang Road, Hexi District, Tianjin, China
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Telephone:
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+86 18630918358 |
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Email:
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jingjinche@aliyun.com |
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Affiliation:
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the Second Hospital of Tianjin Medical Unniversity |
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Name:
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Jingjin Che
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Address:
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23 Pingjiang Road, Hexi District, Tianjin, China
300211
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Telephone:
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+86 18630918358 |
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Email:
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jingjinche@aliyun.com |
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Affiliation:
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the Second Hospital of Tianjin Medical Unniversity |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged between from 18 to 75 years;
2. diagnosed of acute NSTEMI;
3. early PCI within 24 hours is planning according to China PCI guideline in 2016;
4. Severe stenostic or thrombotic lesions in epicardial coronary arteries.
Exclusion criteria: 1. Urgency PCI with 2 hours is indicated, including hemodynamic compromise or cardiogenic shock; refractory angina; malignant arrhythmia; mechanical complications; acute heart failure; transient ST segment elevation;
2. P2Y12 receptor antagonists and/or intensive statin have been used within the 30 days before;
3. Indicators of anticoagulants;
4. Hepatic and renal dysfunction (serum creatinine>221umol/L, AST/ALT above the 5 times of upper limit, or history of cirrosis);
5. Complications of severe infection or malignant neoplasm;
6. Active digestive ulcer, anemia, coagulant dysfunction, or hypersensitive to drugs in this trial;
7. Hematopoitic system disease;
8. History of ischemic or hemorrhagic stroke.
Age minimum:
18
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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acute non-ST-elevation myocardial infarction
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Intervention(s)
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ticagrelor group:180mg loading dose of ticagrelor, followed by 90mg q12h. ;TEG-optimizaed clopidogrel group: 600mg loading dose of clopidogrel, with TEG-guided upstream tirofiban, followed by clopidogrel 75mg/day;intensive statin group:Rosuvastatin of 20mg are given twice in the first 24 hours, followed by 20mg/day;low-dose statin group:Rosuvastatin are given 5mg/day;
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Primary Outcome(s)
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cardiovasular mortality;stent thrombosis;recurrent myocardial infarction;urgent revascularization;ischemic stroke;
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Secondary Outcome(s)
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CK-MB;serum soluble CD40L;MA-ADP;
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Source(s) of Monetary Support
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Health and Family Planning Commision of Tianjin
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Ethics review
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Status: Not approved
Approval date: 26/08/2013
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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