Giving heparin before arrival for people with STEMI who will have primary PCI.

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）

This trial will test whether giving an IV loading dose of unfractionated heparin before hospital arrival helps adults with STEMI who are going for primary PCI.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 6294 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Renmin Hospital of Wuhan University (other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07361783 on ClinicalTrials.gov

What this trial studies

This randomized, multicenter trial plans to enroll about 6,294 adults with STEMI within 12 hours who are scheduled for primary PCI and will randomize them 1:1 across roughly 80 centers. The experimental arm receives an intravenous bolus of unfractionated heparin 100 U/kg within 10 minutes after randomization and before arrival to the catheterization lab, while the control arm is recommended to receive 100 U/kg via the arterial sheath with intraoperative dosing left to the interventional cardiologist. Dual antiplatelet therapy loading is recommended immediately after ECG diagnosis, and patients are not allowed to receive low-molecular-weight heparin, bivalirudin, or glycoprotein IIb/IIIa inhibitors before coronary angiography. Key exclusions include recent thrombolysis, recent anticoagulant or antithrombotic use within 48 hours, cardiopulmonary resuscitation, cardiogenic shock, or mechanical cardiac complications.

Who should consider this trial

Good fit: Adults aged 18 or older with STEMI onset within 12 hours who are planned for primary PCI with an expected first medical contact-to-balloon time under 120 minutes and who have not recently received anticoagulants or thrombolysis.

Not a fit: Patients who recently received thrombolytics or anticoagulant/antithrombotic drugs, those in cardiogenic shock or undergoing CPR, or those with mechanical cardiac complications are excluded and unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, earlier heparin could reduce clot burden and improve artery opening during PCI, lowering heart damage and complications.

How similar studies have performed: Early anticoagulation is commonly used and some observational studies and smaller trials suggest benefit, but large randomized evidence specifically for pre-hospital UFH loading before primary PCI is limited.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years old;
2. 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.
3. Primary PCI was planned if the time from first medical contact to balloon dilatation was expected to be less than 120 minutes.

Exclusion Criteria:

1. Thrombolytic therapy recipients;
2. 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;
3. Patients undergoing cardiopulmonary resuscitation;
4. Patients with cardiogenic shock;
5. 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);
6. 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;
7. Major surgery within one month;
8. Previous history of CABG;
9. Patients with a history of heparin-induced thrombocytopenia or those known to be allergic to anticoagulant or antiplatelet drugs;
10. Combined with other serious diseases and life expectancy less than 12 months;
11. Pregnant or lactating women;
12. Currently participating in clinical research on other drugs or devices;
13. Refuse to sign the informed consent form;
14. The researcher judged that it was not suitable to participate in this study.

Where this trial is running

Wuhan, Hubei

• Renmin Hospital of Wuhan university — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Jing Chen, PhD — Renmin Hospital of Wuhan University
• Study coordinator: Liwei Chen

Conditions: Primary PCI, ST-elevation Myocardial Infarction, Heparin, Primary Percutaneous Coronary Intervation, ST-Elevation Myocardial Infarction