Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07361783

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

Led by Chen Jing · Updated on 2026-01-23

6294

Participants Needed

1

Research Sites

241 weeks

Total Duration

On this page

Sponsors

C

Chen Jing

Lead Sponsor

R

Renmin Hospital of Wuhan University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • STEMI within 12 hours of onset with ST segment elevation in two or more adjacent leads (≥1mm, ≥2mm in leads V2-V3) or new left bundle branch block
  • Planned primary PCI with expected time from first medical contact to balloon dilation less than 120 minutes
Not Eligible

You will not qualify if you...

  • Received thrombolytic therapy
  • Currently taking oral anticoagulants or treated with heparin, low molecular weight heparin, suldaparinol sodium, bivalirudin, or IIb/IIIa receptor antagonists within 48 hours before randomization
  • Undergoing cardiopulmonary resuscitation
  • Experiencing cardiogenic shock
  • Having mechanical complications such as heart wall rupture, ventricular septum perforation, or severe mitral regurgitation
  • History of intracranial aneurysm, arteriovenous malformation, hemorrhage, ischemic stroke, or transient ischemic attack within last 6 months
  • Active bleeding within the last 2 weeks
  • Major surgery within one month
  • Previous coronary artery bypass graft surgery
  • History of heparin-induced thrombocytopenia or allergy to anticoagulant or antiplatelet drugs
  • Serious illness with life expectancy less than 12 months
  • Pregnant or breastfeeding
  • Participating in other clinical trials
  • Refusal to sign informed consent
  • Investigator judgment of unsuitability for participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Renmin Hospital of Wuhan university

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

L

Liwei Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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