Clinical trial NCT05329155: Early Administration of Heparin At FMC for PPCI of STEMI Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: STEMI
Primary PCI
Keywords: Heparin
Primary Percutaneous Coronary Intervention
ST-Elevation Myocardial Infarction
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
Collaborators: name: Xiangyang Central Hospital
name: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
name: Wuhan Central Hospital
name: People's Hospital of Jingshan
name: Chibi General Hospital
name: Xianning Central Hospital
name: Hubei University of Medicine
name: Yichang Central People's Hospital
name: People's Hospital of Tongcheng
name: Ezhou Central Hospital
name: Xiantao First People's Hospital
name: Songzi People's Hospital
name: Anlu People's Hospital
name: Caidian People's Hospital
name: Jiangxia First People's Hospital
name: Jingzhou Central Hospital
name: Hubei Zhongshan Hospital
name: Guoyao Dongfeng General Hospital
name: Wuhan Puren Hospital
name: Shiyan People's Hospital
name: General Hospital of Yangtze River shipping
name: Fifth Hospital in Wuhan
name: CR & WISCO General Hospital
name: Xishui People's Hospital
name: Jiangling People's Hospital
name: Wuhan Third Hospital
name: Laohekou First Hospital
name: The Central Hospital of Huanggang
name: Wuhan No.1 Hospital
name: Hanyang University
name: Wuxue First People's Hospital
name: Tianmen First People's Hospital
name: Xianning First People's Hospital
name: Wuhan No.6 Hospital
name: Wuhan Hospital of Traditional Chinese Medicine
First posted: 2022-04-14
Enrollment: 1145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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; CPR before randomization; Pregnant or lactating woman.

Primary outcomes:
measure: The TIMI 3 flow of the infarct related artery before PPCI
timeFrame: Coronary angiography, before PPCI，anticipated within 2 hours after randomization
Secondary outcomes:
measure: Major adverse cardiovascular or cerebrovascular event
timeFrame: 30 day and 1 year after randomization
measure: Major bleeding
timeFrame: 30 day after randomization
measure: Complete epicardial and myocardial reperfusion after PPCI
timeFrame: within 90min after PPCI
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan university
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Jing Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: