NCT07361783

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,294

participants targeted

Target at P75+ for not_applicable

Timeline
48mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Aug 2025Apr 2030

Study Start

First participant enrolled

August 13, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Primary PCIST-elevation Myocardial Infarction (STEMI)

Keywords

HeparinPrimary Percutaneous Coronary IntervationST-Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

  • The composite endpoint of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke 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

    Within 30 days after randomization.

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

    Major bleeding (BARC type 3\~5)

    within 30 days after randomization

Secondary Outcomes (2)

  • Net Clinical Adverse Event

    With 30 days and 90 days after randomization

  • Individual Clinical Adverse Event

    Within 30 days and 90 days after randomization

Study Arms (2)

Administration of Heparin at the first medical contact

EXPERIMENTAL

The experimental group was treated with a loading dose of 100U/kg of unfractionated heparin at the first medical contact

Drug: Unfractionated heparin

Administration of Heparin in the catheterization laboratory

ACTIVE COMPARATOR

the control group was treated with a loading dose of 100U/kg of unfractionated heparin in the catheterization laboratory.

Drug: Unfractionated heparin

Interventions

Unfractionated heparinDRUG

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)

Administration of Heparin at the first medical contactAdministration of Heparin in the catheterization laboratory

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan university

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Heparin

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Jing Chen, PhD

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liwei Chen

CONTACT

（86）027-88041911renminkjc@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

August 13, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

April 1, 2030

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)