Early Administration of Heparin at FMC for PPCI of STEMI Patients

Study Overview
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Brief Summary
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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 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 the TIMI flow 3 grade ratio in STEMI patients and improve patient's survival and/or reduce MACE rather than in Cathlab.

Detailed Description
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This study will recruit 944 STEMI patients undergoing primary PCI with the symptom onset within 12 hours in 20 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; PCR before randomization; Pregnant or lactating woman;Refused to sign the Informed Consent Form.

Official Title
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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

Conditions
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STEMI, Primary PCI

Intervention / Treatment
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* Drug: Heparin Sodium Injection


Participation Criteria
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Eligibility Criteria
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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; PCR before randomization; Pregnant or lactating woman.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of Heparin in ER<br>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<br>* Heparin Sodium Injection (100U/Kg body weight)<br>|
| Active Comparator: Administration of Heparin in Cathlab<br>Administration of Heparin (100U/Kg body weight) in Cathlab after insertion of artery sheath catheter. | Drug: Heparin Sodium Injection<br>* Heparin Sodium Injection (100U/Kg body weight)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The TIMI 3 flow of the infarct related artery before PCI | The TIMI 3 flow of the infarct related artery at diagnostic angiography before PCI | Coronary angiography, before PCI，anticipated within 2 hours after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular or cerebrovascular event | death, cardiac death, admission for heart failure, myocardial infarction, stent thrombosis, unplanned revascularization, and stroke | 1 year after randomization | 
| Major bleeding | BARC ≥2 | 1 year after randomization | 
| Complete epicardial and myocardial reperfusion 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) 60 minutes after PCI. | within 90min after PPCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heparin, Primary Percutaneous Coronary Intervention, ST-Elevation Myocardial Infarction