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The Impact of Injection of a Loading Dose of Unfractionated Heparin on Patients With Acute ST-segment Elevation Myocardial Infarction Scheduled for Primary PCI at Initial Medical Contact: A Multicenter, Prospective, Randomized Controlled Study(HELP-PCI 2)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Renmin Hospital of Wuhan university
RECRUITING
Wuhan
Contact Information
Primary
Liwei Chen
renminkjc@163.com
(86)027-88041911
Time Frame
Start Date: 2025-08-13
Estimated Completion Date: 2030-04-01
Participants
Target number of participants: 6294
Treatments
Experimental: Administration of Heparin at the first medical contact
The experimental group was treated with a loading dose of 100U/kg of unfractionated heparin at the first medical contact
Active_comparator: Administration of Heparin in the catheterization laboratory
the control group was treated with a loading dose of 100U/kg of unfractionated heparin in the catheterization laboratory.
Related Therapeutic Areas
Sponsors
Collaborators: Xianning Central Hospital, Shiyan People's Hospital, The Central Hospital of Huanggang, Jingzhou Central Hospital, The Third People's Hospital of Hubei Province, Anlu Pu'ai Hospital, Second Xiangya Hospital of Central South University, People's Hospital of Jingshan, Wuhan No.1 Hospital, The First People's Hospital of Tianmen, Renmin Hospital of Wuhan University, Yichang Central People's Hospital, Hubei University of Medicine, Wuhan No.6 Hospital, Jiangxia First People's Hospital, Tongcheng People's Hospital of Anhui province, Sinopharm Dongfeng General Hospital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Xiantao First People's Hospital, Jiangling People's Hospital, China Resources Wugang General Hospital, Songzi People's Hospital, Ezhou Central Hospital, Changjiang Shipping General Hospital, The Second Affiliated Hospital of Harbin Medical University, Wuhan Central Hospital, Wuxue First People's Hospital, Chibi People's Hospital, Xishui County People's Hospital, Wuhan No.3 Hospital, The Fifth Hospital of Wuhan, Wuhan Puren Hospital, Xianning First People's Hospital, Caidian District People's Hospital, Wuhan Hospital of Traditional Chinese Medicine, Hanyang University, Xiangyang Central Hospital, Laohekou First Hospital, Xiangyang Hospital of Traditional Chinese Medicine
Leads: Chen Jing

This content was sourced from clinicaltrials.gov