Primary PCIHELP-PCI-2NCT07361783
Impact of Pre-Hospital Heparin Loading in STEMI Patients for Primary PCI: The HELP-PCI-2 Trial
A study testing Unfractionated heparin treatment in people with Primary PCI and ST-elevation Myocardial Infarction (STEMI), run by Chen Jing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary PCI, ST-elevation Myocardial Infarction (STEMI)
- What is being tested?
- Unfractionated heparin treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,294 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2026to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan university
Wuhan, Hubei, 430000
Jing Chen, PhD, 13659840327, chenjing1982@whu.edu.cn
About this study
Official 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）
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.
- Being tested
- Unfractionated heparin treatment
- Keywords
- Heparin, Primary Percutaneous Coronary Intervation, ST-Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfractionated heparin treatmentDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Unfractionated heparin treatment |
| 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. Receives: Drug: Unfractionated heparin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 30 days after randomization.
Primary safety endpoint: Major bleeding (BARC type 3~5) within 30 days
Major bleeding (BARC type 3~5)
Measured: within 30 days after randomization
Secondary outcomes (2)
Net Clinical Adverse Event
Composite of all-cause death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, stroke, and BARC type 3-5 bleeding
Measured: With 30 days and 90 days after randomization
Individual Clinical Adverse Event
all-cause death, cardiovascular death, recurrent myocardial infarction, urgent coronary revascularization, stent thrombosis, or stroke
Measured: Within 30 days and 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start25 Jan 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary PCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 6,294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Jing
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Xianning Central Hospital, Hubei University of Medicine, Yichang Central People's Hospital, Xiangyang Central Hospital, Caidian District People's Hospital, Chibi People's Hospital, Jiangxia First People's Hospital, Anlu Pu'ai Hospital, Jingzhou Central Hospital, The Fifth Hospital of Wuhan, Shiyan People's Hospital, The Third People's Hospital of Hubei Province, China Resources Wugang General Hospital, Wuhan Puren Hospital, Sinopharm Dongfeng General Hospital, Changjiang Shipping General Hospital, Wuhan No.1 Hospital, Wuhan No.3 Hospital, Xishui County People's Hospital, Xiangyang Hospital of Traditional Chinese Medicine, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Jiangling People's Hospital, Wuhan No.6 Hospital, The Central Hospital of Huanggang, Laohekou First Hospital, Wuxue First People's Hospital, Hanyang University, The First People's Hospital of Tianmen, Xianning First People's Hospital, Wuhan Hospital of Traditional Chinese Medicine, Wuhan Central Hospital, The Second Affiliated Hospital of Harbin Medical University, Second Xiangya Hospital of Central South University, Tongcheng People's Hospital of Anhui province, Songzi People's Hospital, Xiantao First People's Hospital, Ezhou Central Hospital, People's Hospital of Jingshan
- Responsible party
- Sponsor-investigator, Chen Jing, Renmin Hospital of Wuhan University
- Investigators
- Jing Chen, PhD, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361783
- Sponsor's protocol ID
- WDRM2025-K023
- Acronym
- HELP-PCI-2
- Status last verified
- Jun 2026
- First submitted
- 15 Jan 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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）
- ClinicalTrials.gov ID
- NCT07361783
- Acronym / sponsor ID
- HELP-PCI-2 / WDRM2025-K023
- Keywords
- Heparin, Primary Percutaneous Coronary Intervation, ST-Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,294 participants (estimated)
- Lead sponsor
- Chen JingUniversity, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Xianning Central Hospital, Hubei University of Medicine, Yichang Central People's Hospital, Xiangyang Central Hospital, Caidian District People's Hospital, Chibi People's Hospital, Jiangxia First People's Hospital, Anlu Pu'ai Hospital, Jingzhou Central Hospital, The Fifth Hospital of Wuhan, Shiyan People's Hospital, The Third People's Hospital of Hubei Province, China Resources Wugang General Hospital, Wuhan Puren Hospital, Sinopharm Dongfeng General Hospital, Changjiang Shipping General Hospital, Wuhan No.1 Hospital, Wuhan No.3 Hospital, Xishui County People's Hospital, Xiangyang Hospital of Traditional Chinese Medicine, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Jiangling People's Hospital, Wuhan No.6 Hospital, The Central Hospital of Huanggang, Laohekou First Hospital, Wuxue First People's Hospital, Hanyang University, The First People's Hospital of Tianmen, Xianning First People's Hospital, Wuhan Hospital of Traditional Chinese Medicine, Wuhan Central Hospital, The Second Affiliated Hospital of Harbin Medical University, Second Xiangya Hospital of Central South University, Tongcheng People's Hospital of Anhui province, Songzi People's Hospital, Xiantao First People's Hospital, Ezhou Central Hospital, People's Hospital of Jingshan
- Study start
- 25 Jan 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of Heparin at the first medical contact | Experimental | Drug: Unfractionated heparin treatmentThe experimental group was treated with a loading dose of 100U/kg of unfractionated heparin at the first medical contact |
| Administration of Heparin in the catheterization laboratory | Active comparator | Drug: Unfractionated heparin treatmentthe control group was treated with a loading dose of 100U/kg of unfractionated heparin in the catheterization laboratory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfractionated heparin treatmentAn 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) | Drug | Administration of Heparin at the first medical contact, Administration of Heparin in the catheterization laboratory |
Primary outcome
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
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)
2 secondary outcomes
Net Clinical Adverse Event
Time frame: With 30 days and 90 days after randomization
Individual Clinical Adverse Event
Time frame: Within 30 days and 90 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Chen, PhD principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unfractionated heparin treatment in people with Primary PCI and ST-elevation Myocardial Infarction (STEMI), run by Chen Jing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liwei Chen (（86）027-88041911 ext. 86346, renminkjc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.