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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05329155
Other study ID # WDRY2022-K089
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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