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| Name | Class |
|---|---|
| Renmin Hospital of Wuhan University | OTHER |
| Xianning Central Hospital | OTHER |
| Hubei University of Medicine | OTHER |
| Yichang Central People's Hospital |
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This randomized, multicenter, prospective trial will enroll 6,294 participants in approximately 80 centers. STEMI patients with onset time within 12 hours and scheduled for primary PCI will be randomly assigned to two groups in a 1:1 ratio. Patients meeting the criteria were randomly assigned. It is recommended that loading doses of dual antiplatelet therapy be administered immediately after electrocardiogram diagnosis. The experimental group was required to be given an intravenous injection of 100 U/kg of UFH within 10 minutes after randomization, and this should be completed at least before delivery to the catheter lab. The control group was recommended to be given 100 U/kg of UFH through the arterial sheath, but the actual intraoperative dosage was determined by the interventional cardiologist. No patient is allowed to use low-molecular-weight heparin, bivalirudin, glycoprotein IIb/IIIa inhibitors or other antithrombotic drugs before coronary angiography. The planned enrollment period for this study is 24 months. The scheduled follow-up visits will occur at 30 days (±7 days), 3 months (±14 days), and if conditions permit, at 6 months (±30 days) and 1 year (±30 days) after randomization. The purpose of this study is to evaluate the composite endpoint of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke within 30 days after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Heparin at the first medical contact | Experimental | The experimental group was treated with a loading dose of 100U/kg of unfractionated heparin at the first medical contact |
|
| Administration of Heparin in the catheterization laboratory | Active Comparator | the control group was treated with a loading dose of 100U/kg of unfractionated heparin in the catheterization laboratory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unfractionated heparin treatment | Drug | An intravenous injection of 100 U/kg of UFH will be given at first medical contact before primary PCI (if assigned to experimental group) or in the catheter lab through the arterial sheath when starting primary PCI (if assigned to control group) |
| Measure | Description | Time Frame |
|---|---|---|
| The composite endpoint of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke within 30 days after randomization | The composite endpoint of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke within 30 days after randomization | Within 30 days after randomization. |
| Primary safety endpoint: Major bleeding (BARC type 3~5) within 30 days | Major bleeding (BARC type 3~5) | within 30 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Net Clinical Adverse Event | Composite of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, stroke, and BARC type 3-5 bleeding | With 30 days and 90 days after randomization |
| Individual Clinical Adverse Event |
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Inclusion Criteria:
Age ≥18 years old;
STEMI within 12 hours of onset Newly developed adjacent two or more leads with ST segment elevation of ≥1mm (lead V2-V3 elevation of ≥2mm).
Newly developed left bundle branch block (LBBB). In the right bundle-branch block (RBBB), the ST segment of leads V1-V3 is elevated or Q waves occur.
Primary PCI was planned if the time from first medical contact to balloon dilatation was expected to be less than 120 minutes.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liwei Chen | Contact | (86)027-88041911 | 86346 | renminkjc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Chen, PhD | Renmin Hospital of Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital of Wuhan university | Recruiting | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Xiangyang Central Hospital | OTHER |
| Caidian District People's Hospital | UNKNOWN |
| Chibi People's Hospital | UNKNOWN |
| Jiangxia First People's Hospital | UNKNOWN |
| Anlu Pu'ai Hospital | UNKNOWN |
| Jingzhou Central Hospital | OTHER |
| The Fifth Hospital of Wuhan | OTHER |
| Shiyan People's Hospital | UNKNOWN |
| The Third People's Hospital of Hubei Province | OTHER |
| China Resources Wugang General Hospital | UNKNOWN |
| Wuhan Puren Hospital | OTHER |
| Sinopharm Dongfeng General Hospital | UNKNOWN |
| Changjiang Shipping General Hospital | UNKNOWN |
| Wuhan No.1 Hospital | OTHER |
| Wuhan No.3 Hospital | UNKNOWN |
| Xishui County People's Hospital | UNKNOWN |
| Xiangyang Hospital of Traditional Chinese Medicine | OTHER |
| The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture | OTHER |
| Jiangling People's Hospital | UNKNOWN |
| Wuhan No.6 Hospital | UNKNOWN |
| The Central Hospital of Huanggang | OTHER |
| Laohekou First Hospital | UNKNOWN |
| Wuxue First People's Hospital | UNKNOWN |
| Hanyang University | OTHER |
| The First People's Hospital of Tianmen | UNKNOWN |
| Xianning First People's Hospital | UNKNOWN |
| Wuhan Hospital of Traditional Chinese Medicine | OTHER |
| Wuhan Central Hospital | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| Second Xiangya Hospital of Central South University | OTHER |
| Tongcheng People's Hospital of Anhui province | UNKNOWN |
| Songzi People's Hospital | UNKNOWN |
| Xiantao First People's Hospital | UNKNOWN |
| Ezhou Central Hospital | OTHER |
| People's Hospital of Jingshan | UNKNOWN |
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|
all-cause death, cardiovascular death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke |
| Within 30 days and 90 days after randomization |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |