NCT05329155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

March 29, 2022

Last Update Submit

March 24, 2025

Conditions

STEMIPrimary PCI

Keywords

HeparinPrimary Percutaneous Coronary InterventionST-Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • The TIMI 3 flow of the infarct related artery before PPCI

    The TIMI 3 flow of the infarct related artery at diagnostic angiography before PPCI

    Coronary angiography, before PPCI，anticipated within 2 hours after randomization

Secondary Outcomes (3)

  • Major adverse cardiovascular or cerebrovascular event

    30 day and 1 year after randomization

  • Major bleeding

    30 day after randomization

  • Complete epicardial and myocardial reperfusion after PPCI

    within 90min after PPCI

Study Arms (2)

Administration of Heparin in ER

EXPERIMENTAL

Administration of Heparin (100U/Kg body weight) with loading dose of DAPT (Aspirin 300mg and Ticagrelor 180mg) at first medical contact for STEMI patients intended to perform PPCI.

Drug: Heparin Sodium Injection

Administration of Heparin in Cathlab

ACTIVE COMPARATOR

Administration of Heparin (100U/Kg body weight) in Cathlab after insertion of artery sheath catheter.

Drug: Heparin Sodium Injection

Interventions

Heparin Sodium InjectionDRUG

Heparin Sodium Injection (100U/Kg body weight)

Administration of Heparin in CathlabAdministration of Heparin in ER

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan university

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Heparin

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Jing Chen, PhD

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 14, 2022

Study Start

July 20, 2022

Primary Completion

August 20, 2023

Study Completion

August 20, 2024

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)