Impact of Pre-Hospital Heparin Loading in STEMI Patients for Primary PCI: The HELP-PCI 2 Trial
Status:
RECRUITING
Trial end date:
2030-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
NA
Details
Lead Sponsor:
Chen Jing
Collaborators:
Anlu Pu'ai Hospital Caidian District People's Hospital Changjiang Shipping General Hospital Chibi People's Hospital China Resources Wugang General Hospital Ezhou Central Hospital Hanyang University Hubei University of Medicine Jiangling People's Hospital Jiangxia First People's Hospital Jingzhou Central Hospital Laohekou First Hospital People's Hospital of Jingshan Renmin Hospital of Wuhan University Second Xiangya Hospital of Central South University Shiyan People's Hospital Sinopharm Dongfeng General Hospital Songzi People's Hospital The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture The Central Hospital of Huanggang The Fifth Hospital of Wuhan The First People's Hospital of Tianmen The Second Affiliated Hospital of Harbin Medical University The Third People's Hospital of Hubei Province Tongcheng People's Hospital of Anhui province Wuhan Central Hospital Wuhan Hospital of Traditional Chinese Medicine Wuhan No.1 Hospital Wuhan No.3 Hospital Wuhan No.6 Hospital Wuhan Puren Hospital Wuxue First People's Hospital Xiangyang Central Hospital Xiangyang Hospital of Traditional Chinese Medicine Xianning Central Hospital Xianning First People's Hospital Xiantao First People's Hospital Xishui County People's Hospital Yichang Central People's Hospital