Impact of Pre-Hospital Heparin Loading in STEMI Patients for Primary PCI: The HELP-PCI-2 Trial

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.

NCT Number	NCT07361783
Lead Sponsor	Chen Jing Collaborators: Renmin Hospital of Wuhan University, Xianning Central Hospital, Hubei University of Medicine, Yichang Central People's Hospital, Xiangyang Central Hospital, Caidian District People's Hospital, Chibi People's Hospital, Jiangxia First People's Hospital, Anlu Pu'ai Hospital, Jingzhou Central Hospital, The Fifth Hospital of Wuhan, Shiyan People's Hospital, The Third People's Hospital of Hubei Province, China Resources Wugang General Hospital, Wuhan Puren Hospital, Sinopharm Dongfeng General Hospital, Changjiang Shipping General Hospital, Wuhan No.1 Hospital, Wuhan No.3 Hospital, Xishui County People's Hospital, Xiangyang Hospital of Traditional Chinese Medicine, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Jiangling People's Hospital, Wuhan No.6 Hospital, The Central Hospital of Huanggang, Laohekou First Hospital, Wuxue First People's Hospital, Hanyang University, The First People's Hospital of Tianmen, Xianning First People's Hospital, Wuhan Hospital of Traditional Chinese Medicine, Wuhan Central Hospital, The Second Affiliated Hospital of Harbin Medical University, Second Xiangya Hospital of Central South University, Tongcheng People's Hospital of Anhui province, Songzi People's Hospital, Xiantao First People's Hospital, Ezhou Central Hospital, People's Hospital of Jingshan
Conditions	Primary PCI, ST-elevation Myocardial Infarction (STEMI)
Enrollment	6,294 participants
Start Date	2026-01-25
Primary Completion	2029-12-31 (estimated)
Study Completion	2030-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-17