Early Administration of Heparin at FMC for PPCI of STEMI Patients (HELP-PPCI)

W

Wuhan University

Status

Active, not recruiting

Conditions

STEMI
Primary PCI

Treatments

Drug: Heparin Sodium Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT05329155
WDRY2022-K089

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,144 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,144 participants in 2 patient groups

Administration of Heparin in ER
Experimental group
Description:
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.
Treatment:
Drug: Heparin Sodium Injection
Administration of Heparin in Cathlab
Active Comparator group
Description:
Administration of Heparin (100U/Kg body weight) in Cathlab after insertion of artery sheath catheter.
Treatment:
Drug: Heparin Sodium Injection

Trial contacts and locations

1

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Central trial contact

Liwei Chen

Data sourced from clinicaltrials.gov

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