NCT07361783

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,294 (estimated)
• Sponsor: Chen Jing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary PCI
• ST-elevation Myocardial Infarction (STEMI)

Interventions

Type	Name	Description
DRUG	Unfractionated heparin	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)

Timeline

• Start date: 2025-08-13
• Primary completion: 2029-12-31
• Completion: 2030-04-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: China