Early Administration of Heparin at FMC for PPCI of STEMI Patients

Not Applicable

Completed

• Conditions: STEMI; Primary PCI
• Interventions: Drug: Heparin Sodium Injection

• Registration Number: NCT05329155
• Lead Sponsor: Renmin Hospital of Wuhan University

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.

Study Timeline

• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Study Start: 2022-07-20
• Primary Completion: 2023-08-20
• Study Completion: 2024-08-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1144

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Administration of Heparin in Cathlab	Heparin Sodium Injection	Administration of Heparin (100U/Kg body weight) in Cathlab after insertion of artery sheath catheter.
Administration of Heparin in ER	Heparin Sodium Injection	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.

Primary Outcome Measures

Name	Time	Method
The TIMI 3 flow of the infarct related artery before PCI	Coronary angiography, before PCI，anticipated within 2 hours after randomization	The TIMI 3 flow of the infarct related artery at diagnostic angiography before PCI

Secondary Outcome Measures

Name	Time	Method
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
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 PCI.

Trial Locations

Locations (1)

Renmin Hospital of Wuhan university; 🇨🇳 Wuhan, Hubei, China