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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: renminkjc@163.com
• Phone: （86）027-88041911

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Drug-coated balloons vs drug-eluting stents for immediate slow-flow/no-reflow in STEMI with high thrombus

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• CHIP in STEMI: Does clonal hematopoiesis influence infarct severity

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• Digitally supported personalized nutrition to improve heart pumping after ST‑elevation heart attack

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• Investigating microplastics in patients with heart attacks

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• PDGFRβ PET imaging to detect cardiac fibrosis after heart attack or in HFpEF

  This project will test whether a PET tracer that binds PDGFRβ can spot fibrogenic cells in the hearts of people after a STEMI, in patients with HFpEF, and in healthy volunteers.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.