Early Administration of Heparin At FMC for PPCI of STEMI Patients

Effectiveness and Safety of Early Administration of Heparin At First Medical Contact for STEMI Patients Undergoing Primary Percutaneous Coronary Intervention: a Multicenter, Prospective, Randomized, Controlled Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05329155

Acronym

HELP-PCI

Enrollment

1145

Registered

2022-04-14

Start date

2022-07-20

Completion date

2024-08-20

Last updated

2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI, Primary PCI

Keywords

Heparin, Primary Percutaneous Coronary Intervention, ST-Elevation Myocardial Infarction

Brief summary

Heparin is the first choice of anticoagulation drug for primary PCI of STEMI patients. However, the priority of use of hepairn in first medical contact or in Cathlab has not yet studied. Previous study revealed early use of antithrombotic drugs could improve patient's survival. Here we supposed that use of heparin at first medical contact could increase the TIMI flow 3 grade ratio in STEMI patients and improve patient's survival and/or reduce MACE rather than in Cathlab.

Detailed description

This study will recruit 944 STEMI patients undergoing primary PCI with the symptom onset within 12 hours in 36 hospitals in Hubei Province, China. The patients will be 1:1 randomly assigned to the intervention group (IG) and control group (CG). Patients in IG will be intravenously administrated with sodium heparin (100U/Kg) at first medical contact, while patients in CG will be administrated with sodium heparin (100U/Kg) through catheter sheath in the CathLab. Inclusion Criteria: STEMI patient; Symptom onset in 12 hours; Intended to perform PPCI. Exclusion Criteria:Active bleeding; Life expectancy less than 1 year; History of heparin-induced thrombocytopenia; Mechanical complication of MI (VSR, acute MR); History of CABG; On Coagulation drugs; CPR before randomization; Pregnant or lactating woman;Refused to sign the Informed Consent Form.

Interventions

DRUGHeparin Sodium Injection

Heparin Sodium Injection (100U/Kg body weight)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* STEMI patient; Symptom onset in 12 hours; Intended to perform PPCI

Exclusion criteria

* Active bleeding; Life expectancy less than 1 year; History of heparin-induced thrombocytopenia; Mechanical complication of MI (VSR, acute MR); History of CABG; On Coagulation drugs; CPR before randomization; Pregnant or lactating woman.

Design outcomes

Primary

Measure	Time frame	Description
The TIMI 3 flow of the infarct related artery before PPCI	Coronary angiography, before PPCI，anticipated within 2 hours after randomization	The TIMI 3 flow of the infarct related artery at diagnostic angiography before PPCI

Secondary

Measure	Time frame	Description
Complete epicardial and myocardial reperfusion after PPCI	within 90min after PPCI	Thrombolysis in myocardial infarction (TIMI) flow grade (TFG) 3 for epicardial reperfusion and TIMI myocardial perfusion (TMPG) grade 3 for myocardial reperfusion and complete (≥70%) ST-segment resolution of the initial sum of ST-segment elevation (STR) 90 minutes after PPCI.
Major adverse cardiovascular or cerebrovascular event	30 day and 1 year after randomization	death, cardiac death, admission for heart failure, myocardial infarction, stent thrombosis, unplanned revascularization, and stroke
Major bleeding	30 day after randomization	BARC ≥2

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026