Early Administration of Heparin at FMC for PPCI of STEMI Patients (HELP-PPCI)
Primary Purpose
STEMI, Primary PCI
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Heparin Sodium Injection
Sponsored by
About this trial
This is an interventional treatment trial for STEMI focused on measuring Heparin, Primary Percutaneous Coronary Intervention, ST-Elevation Myocardial Infarction
Eligibility Criteria
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.
Sites / Locations
- Renmin Hospital of Wuhan universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Administration of Heparin in ER
Administration of Heparin in Cathlab
Arm 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.
Administration of Heparin (100U/Kg body weight) in Cathlab after insertion of artery sheath catheter.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Major adverse cardiovascular or cerebrovascular event
death, cardiac death, admission for heart failure, myocardial infarction, stent thrombosis, unplanned revascularization, and stroke
Major bleeding
BARC ≥2
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.
Full Information
NCT ID
NCT05329155
First Posted
March 29, 2022
Last Updated
July 29, 2022
Sponsor
Renmin Hospital of Wuhan University
Collaborators
The First College of Clinical Medical Science, China Three Gorges University, Xiangyang Central Hospital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Wuhan Central Hospital, People's Hospital of Jingshan, Chibi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05329155
Brief Title
Early Administration of Heparin at FMC for PPCI of STEMI Patients
Acronym
HELP-PPCI
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Renmin Hospital of Wuhan University
Collaborators
The First College of Clinical Medical Science, China Three Gorges University, Xiangyang Central Hospital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Wuhan Central Hospital, People's Hospital of Jingshan, Chibi General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI, Primary PCI
Keywords
Heparin, Primary Percutaneous Coronary Intervention, ST-Elevation Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
944 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Administration of Heparin in ER
Arm Type
Experimental
Arm 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.
Arm Title
Administration of Heparin in Cathlab
Arm Type
Active Comparator
Arm Description
Administration of Heparin (100U/Kg body weight) in Cathlab after insertion of artery sheath catheter.
Intervention Type
Drug
Intervention Name(s)
Heparin Sodium Injection
Intervention Description
Heparin Sodium Injection (100U/Kg body weight)
Primary Outcome Measure Information:
Title
The TIMI 3 flow of the infarct related artery before PCI
Description
The TIMI 3 flow of the infarct related artery at diagnostic angiography before PCI
Time Frame
Coronary angiography, before PCI,anticipated within 2 hours after randomization
Secondary Outcome Measure Information:
Title
Major adverse cardiovascular or cerebrovascular event
Description
death, cardiac death, admission for heart failure, myocardial infarction, stent thrombosis, unplanned revascularization, and stroke
Time Frame
1 year after randomization
Title
Major bleeding
Description
BARC ≥2
Time Frame
1 year after randomization
Title
Complete epicardial and myocardial reperfusion after PPCI
Description
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.
Time Frame
within 90min after PPCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liwei Chen
Phone
(86)027-88041911
Ext
86346
Email
renminkjc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Chen, PhD
Organizational Affiliation
Renmin Hospital of Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renmin Hospital of Wuhan university
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Chen, PhD
Phone
13659840327
Email
chenjing1982@whu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Administration of Heparin at FMC for PPCI of STEMI Patients
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