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

Official title

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）

Overview

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.

Interventions

• Drug Unfractionated heparin treatment
  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)

Primary outcome measures

• The composite endpoint of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke within 30 days after randomization [Time frame: Within 30 days after randomization.]
• Primary safety endpoint: Major bleeding (BARC type 3~5) within 30 days [Time frame: within 30 days after randomization]

Secondary outcome measures (2)

• Net Clinical Adverse Event [Time frame: With 30 days and 90 days after randomization]
• Individual Clinical Adverse Event [Time frame: Within 30 days and 90 days after randomization]

Eligibility criteria

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

• Thrombolytic therapy recipients;
• Currently taking oral anticoagulant drugs or having been treated with heparin, low molecular weight heparin, suldaparinol sodium, bivalirudin or IIb/IIIa receptor antagonists within 48 hours before randomization;
• Patients undergoing cardiopulmonary resuscitation;
• Patients with cardiogenic shock;
• Combined mechanical complications (rupture of the free wall of the heart, perforation of the ventricular septum, insufficiency or rupture of the papillary muscle leading to severe mitral regurgitation);
• History of intracranial parenchymal aneurysm, intracranial arteriovenous malformation, intracranial hemorrhage, ischemic stroke or transient ischemic attack within the last 6 months, and active hemorrhage within the last 2 weeks;
• Major surgery within one month;
• Previous history of CABG;
• Patients with a history of heparin-induced thrombocytopenia or those known to be allergic to anticoagulant or antiplatelet drugs;
• Combined with other serious diseases and life expectancy less than 12 months;
• Pregnant or lactating women;
• Currently participating in clinical research on other drugs or devices;
• Refuse to sign the informed consent form;
• The researcher judged that it was not suitable to participate in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Renmin Hospital of Wuhan university — Wuhan

Identifiers

NCT: NCT07361783 · WDRM2025-K023

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗