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NCT Number: NCT07361783

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renmin Hospital of Wuhan university

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

Jing Chen, PhD

CONTACT

[email protected]

13659840327

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unfractionated heparin treatment

Drug

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 outcomes

  1. 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.

    The composite endpoint of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke within 30 days after randomization

  2. Primary safety endpoint: Major bleeding (BARC type 3~5) within 30 days

    Time frame: within 30 days after randomization

    Major bleeding (BARC type 3~5)

Secondary outcomes

  1. Net Clinical Adverse Event

    Time frame: With 30 days and 90 days after randomization

    Composite of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, stroke, and BARC type 3-5 bleeding

  2. Individual Clinical Adverse Event

    Time frame: Within 30 days and 90 days after randomization

    all-cause death, cardiovascular death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Liwei Chen

CONTACT

[email protected]

(86)027-88041911 ext. 86346

Sponsors and collaborators

Lead sponsor

Chen Jing

Other

Collaborators

  • Anlu Pu'ai Hospital
  • Caidian District People's Hospital
  • Changjiang Shipping General Hospital
  • Chibi People's Hospital
  • China Resources Wugang General Hospital
  • Ezhou Central Hospital
  • Hanyang University
  • Hubei University of Medicine
  • Jiangling People's Hospital
  • Jiangxia First People's Hospital
  • Jingzhou Central Hospital
  • Laohekou First Hospital
  • People's Hospital of Jingshan
  • Renmin Hospital of Wuhan University
  • Second Xiangya Hospital of Central South University
  • Shiyan People's Hospital
  • Sinopharm Dongfeng General Hospital
  • Songzi People's Hospital
  • The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
  • The Central Hospital of Huanggang
  • The Fifth Hospital of Wuhan
  • The First People's Hospital of Tianmen
  • The Second Affiliated Hospital of Harbin Medical University
  • The Third People's Hospital of Hubei Province
  • Tongcheng People's Hospital of Anhui province
  • Wuhan Central Hospital
  • Wuhan Hospital of Traditional Chinese Medicine
  • Wuhan No.1 Hospital
  • Wuhan No.3 Hospital
  • Wuhan No.6 Hospital
  • Wuhan Puren Hospital
  • Wuxue First People's Hospital
  • Xiangyang Central Hospital
  • Xiangyang Hospital of Traditional Chinese Medicine
  • Xianning Central Hospital
  • Xianning First People's Hospital
  • Xiantao First People's Hospital
  • Xishui County People's Hospital
  • Yichang Central People's Hospital

Registry information

Official study 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)

Acronym: HELP-PCI-2

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jan 23, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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