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

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

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)

Sponsors & Collaborators

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Xianning Central Hospital

  collaborator OTHER

• Hubei University of Medicine

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• Xiangyang Central Hospital

  collaborator OTHER

• Caidian District People's Hospital

  collaborator UNKNOWN

• Chibi People's Hospital

  collaborator UNKNOWN

• Jiangxia First People's Hospital

  collaborator UNKNOWN

• Anlu Pu'ai Hospital

  collaborator UNKNOWN

• Jingzhou Central Hospital

  collaborator OTHER

• The Fifth Hospital of Wuhan

  collaborator OTHER

• Shiyan People's Hospital

  collaborator UNKNOWN

• The Third People's Hospital of Hubei Province

  collaborator OTHER

• China Resources Wugang General Hospital

  collaborator UNKNOWN

• Wuhan Puren Hospital

  collaborator OTHER

• Sinopharm Dongfeng General Hospital

  collaborator UNKNOWN

• Changjiang Shipping General Hospital

  collaborator UNKNOWN

• Wuhan No.1 Hospital

  collaborator OTHER

• Wuhan No.3 Hospital

  collaborator UNKNOWN

• Xishui County People's Hospital

  collaborator UNKNOWN

• Xiangyang Hospital of Traditional Chinese Medicine

  collaborator OTHER

• The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture

  collaborator OTHER

• Jiangling People's Hospital

  collaborator UNKNOWN

• Wuhan No.6 Hospital

  collaborator UNKNOWN

• The Central Hospital of Huanggang

  collaborator OTHER

• Laohekou First Hospital

  collaborator UNKNOWN

• Wuxue First People's Hospital

  collaborator UNKNOWN

• Hanyang University

  collaborator OTHER

• The First People's Hospital of Tianmen

  collaborator UNKNOWN

• Xianning First People's Hospital

  collaborator UNKNOWN

• Wuhan Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Wuhan Central Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Tongcheng People's Hospital of Anhui province

  collaborator UNKNOWN

• Songzi People's Hospital

  collaborator UNKNOWN

• Xiantao First People's Hospital

  collaborator UNKNOWN

• Ezhou Central Hospital

  collaborator OTHER

• People's Hospital of Jingshan

  collaborator UNKNOWN

• Chen Jing

  lead OTHER

Principal Investigators

• Jing Chen, PhD · Renmin Hospital of Wuhan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-25

Primary Completion

2029-12-31

Completion

2030-04-01

Countries

• China

Study Locations