Early Administration of Heparin at FMC for PPCI of STEMI Patients

STEMI Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05329155
• Other study ID #: WDRY2022-K089
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: August 20, 2024

Study information

• Verified date: January 2024
• Source: Renmin Hospital of Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1144
• Est. completion date: August 20, 2024
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Primary PCI
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Drug:
• Heparin Sodium Injection
Heparin Sodium Injection (100U/Kg body weight)

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan university	Wuhan	Hubei

Sponsors (36)

Lead Sponsor

Collaborator

Renmin Hospital of Wuhan University

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Major bleeding	BARC =2	30 day after randomization
Secondary	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