Impact of Pre-Hospital Heparin Loading in STEMI Patients for Primary PCI: The HELP-PCI-2 Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChen Jing
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Unfractionated heparin treatment
Treatment groups
6,294 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chen Jing
Lead sponsor
Renmin Hospital of Wuhan University
Sponsor institution
Renmin Hospital of Wuhan University
Collaborator
Xianning Central Hospital
Collaborator
Hubei University of Medicine
Collaborator
Yichang Central People's Hospital
Collaborator
Xiangyang Central Hospital
Collaborator
Caidian District People's Hospital
Collaborator
Chibi People's Hospital
Collaborator
Jiangxia First People's Hospital
Collaborator
Anlu Pu'ai Hospital
Collaborator
Jingzhou Central Hospital
Collaborator
The Fifth Hospital of Wuhan
Collaborator
Shiyan People's Hospital
Collaborator
The Third People's Hospital of Hubei Province
Collaborator
China Resources Wugang General Hospital
Collaborator
Wuhan Puren Hospital
Collaborator
Sinopharm Dongfeng General Hospital
Collaborator
Changjiang Shipping General Hospital
Collaborator
Wuhan No.1 Hospital
Collaborator
Wuhan No.3 Hospital
Collaborator
Xishui County People's Hospital
Collaborator
Xiangyang Hospital of Traditional Chinese Medicine
Collaborator
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Collaborator
Jiangling People's Hospital
Collaborator
Wuhan No.6 Hospital
Collaborator
The Central Hospital of Huanggang
Collaborator
Laohekou First Hospital
Collaborator
Wuxue First People's Hospital
Collaborator
Hanyang University
Collaborator
The First People's Hospital of Tianmen
Collaborator
Xianning First People's Hospital
Collaborator
Wuhan Hospital of Traditional Chinese Medicine
Collaborator
Wuhan Central Hospital
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Tongcheng People's Hospital of Anhui province
Collaborator
Songzi People's Hospital
Collaborator
Xiantao First People's Hospital
Collaborator
Ezhou Central Hospital
Collaborator
People's Hospital of Jingshan
Collaborator
Source ClinicalTrials.gov