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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: STEMI; Primary PCI
• Intervention / Treatment: Drug: Heparin Sodium Injection

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 Type: Interventional
• Enrollment (Actual): 1144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liwei Chen; Phone Number: 86346 （86）027-88041911; Email: renminkjc@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Renmin Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
Major adverse cardiovascular or cerebrovascular event	death, cardiac death, admission for heart failure, myocardial infarction, stent thrombosis, unplanned revascularization, and stroke	30 day and 1 year after randomization
Major bleeding	BARC ≥2	30 day after randomization

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Collaborators: Yichang Central People's Hospital; Wuhan Central Hospital; Wuhan No.1 Hospital; Xiangyang Central Hospital; Wuhan Third Hospital; Wuhan Hospital of Traditional Chinese Medicine; Jingzhou Central Hospital; Wuhan Puren Hospital; The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture; Wuhan Hanyang Hospital; Xianning Central Hospital; Huanggang Central Hospital; Fifth Hospital in Wuhan; Ezhou Central Hospital; Suizhou Central Hospital; People's Hospital of Jingshan; Chibi General Hospital; People's Hospital of Tongcheng; Xiantao First People's Hospital; Songzi People's Hospital; Anlu People's Hospital; Caidian People's Hospital; Jiangxia First People's Hospital; Hubei Zhongshan Hospital; Guoyao Dongfeng General Hospital; Shiyan People's Hospital; General Hospital of Yangtze River shipping; CR & WISCO General Hospital; Xishui People's Hospital; Jiangling People's Hospital; Laohekou First Hospital; Wuxue First People's Hospital; Tianmen First People's Hospital; Xianning First People's Hospital; Wuhan No.6 Hospital
• Investigators: Principal Investigator: Jing Chen, PhD, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Actual): August 20, 2023
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Heparin; ST-Elevation Myocardial Infarction; Primary Percutaneous Coronary Intervention
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: WDRY2022-K089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No