Impact of Pre-Hospital Heparin Loading in STEMI Patients for Primary PCI: The HELP-PCI-2 Trial (NCT07361783) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Pre-Hospital Heparin Loading in STEMI Patients for Primary PCI: The HELP-PCI-2 Trial
China6,294 participantsStarted 2026-01-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether giving heparin in the ambulance before reaching the hospital can improve outcomes in STEMI patients — given that I've just had or am at risk of a STEMI, is the timing of heparin treatment something that could genuinely affect my situation, and is this trial worth discussing for my case?
2The trial's main safety concern is major bleeding, which they're classifying as 'BARC type 3 to 5' — can you explain what that level of bleeding risk means in practical terms for me, and how it compares to the bleeding risk I'd face with standard heparin given at the hospital?
3Since this trial is listed as Phase NA rather than a traditional Phase 1, 2, or 3, what does that tell us about how much is already known about the safety and effectiveness of pre-hospital heparin loading, and should that affect how I think about participating?
4The trial is tracking serious events like death, another heart attack, stroke, and stent thrombosis over 30 days — does my specific heart attack history, clotting risk, or other health conditions make me more or less likely to be affected by those outcomes, and how does that shape whether this trial might or might not be a good fit to discuss?
5If I don't join this trial, what is the current standard of care for heparin timing in STEMI patients being treated with primary PCI, and would I receive that standard treatment regardless of whether I participate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The composite endpoint of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke within 30 days after randomization
Timeframe: Within 30 days after randomization.
2
Primary safety endpoint: Major bleeding (BARC type 3~5) within 30 days
. 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;