STEMIHELP-PCINCT05329155
Early Administration of Heparin At FMC for PPCI of STEMI Patients
A study testing Heparin Sodium Injection in people with STEMI and Primary PCI, run by Renmin Hospital of Wuhan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI, Primary PCI
- What is being tested?
- Heparin Sodium Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,145 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2022to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI patient; Symptom onset in 12 hours; Intended to perform PPCI
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- STEMI, Primary PCI
- Being tested
- Heparin Sodium Injection
- Keywords
- Heparin, Primary Percutaneous Coronary Intervention, ST-Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin Sodium InjectionDrug
Heparin Sodium Injection (100U/Kg body weight)
| Study group | Role | What they receive |
|---|---|---|
| Administration of Heparin in ER | Experimental | 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. Receives: Drug: Heparin Sodium Injection |
| Administration of Heparin in Cathlab | Active comparator | Administration of Heparin (100U/Kg body weight) in Cathlab after insertion of artery sheath catheter. Receives: Drug: Heparin Sodium Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The TIMI 3 flow of the infarct related artery before PPCI
The TIMI 3 flow of the infarct related artery at diagnostic angiography before PPCI
Measured: Coronary angiography, before PPCI，anticipated within 2 hours after randomization
Secondary outcomes (3)
Major adverse cardiovascular or cerebrovascular event
death, cardiac death, admission for heart failure, myocardial infarction, stent thrombosis, unplanned revascularization, and stroke
Measured: 30 day and 1 year after randomization
Major bleeding
BARC ≥2
Measured: 30 day after randomization
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) 90 minutes after PPCI.
Measured: within 90min after PPCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start20 Jul 2022
- Primary completion20 Aug 2023
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangyang Central Hospital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Wuhan Central Hospital, People's Hospital of Jingshan, Chibi General Hospital, Xianning Central Hospital, Hubei University of Medicine, Yichang Central People's Hospital, People's Hospital of Tongcheng, Ezhou Central Hospital, Xiantao First People's Hospital, Songzi People's Hospital, Anlu People's Hospital, Caidian People's Hospital, Jiangxia First People's Hospital, Jingzhou Central Hospital, Hubei Zhongshan Hospital, Guoyao Dongfeng General Hospital, Wuhan Puren Hospital, Shiyan People's Hospital, General Hospital of Yangtze River shipping, Fifth Hospital in Wuhan, CR & WISCO General Hospital, Xishui People's Hospital, Jiangling People's Hospital, Wuhan Third Hospital, Laohekou First Hospital, The Central Hospital of Huanggang, Wuhan No.1 Hospital, Hanyang University, Wuxue First People's Hospital, Tianmen First People's Hospital, Xianning First People's Hospital, Wuhan No.6 Hospital, Wuhan Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Chen Jing, Renmin Hospital of Wuhan University
- Investigators
- Jing Chen, PhD, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329155
- Sponsor's protocol ID
- WDRY2022-K089
- Acronym
- HELP-PCI
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05329155
- Acronym / sponsor ID
- HELP-PCI / WDRY2022-K089
- Conditions
- STEMI, Primary PCI
- Keywords
- Heparin, Primary Percutaneous Coronary Intervention, ST-Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,145 participants (actual)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- Xiangyang Central Hospital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Wuhan Central Hospital, People's Hospital of Jingshan, Chibi General Hospital, Xianning Central Hospital, Hubei University of Medicine, Yichang Central People's Hospital, People's Hospital of Tongcheng, Ezhou Central Hospital, Xiantao First People's Hospital, Songzi People's Hospital, Anlu People's Hospital, Caidian People's Hospital, Jiangxia First People's Hospital, Jingzhou Central Hospital, Hubei Zhongshan Hospital, Guoyao Dongfeng General Hospital, Wuhan Puren Hospital, Shiyan People's Hospital, General Hospital of Yangtze River shipping, Fifth Hospital in Wuhan, CR & WISCO General Hospital, Xishui People's Hospital, Jiangling People's Hospital, Wuhan Third Hospital, Laohekou First Hospital, The Central Hospital of Huanggang, Wuhan No.1 Hospital, Hanyang University, Wuxue First People's Hospital, Tianmen First People's Hospital, Xianning First People's Hospital, Wuhan No.6 Hospital, Wuhan Hospital of Traditional Chinese Medicine
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of Heparin in ER | Experimental | Drug: Heparin Sodium InjectionAdministration 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 in Cathlab | Active comparator | Drug: Heparin Sodium InjectionAdministration of Heparin (100U/Kg body weight) in Cathlab after insertion of artery sheath catheter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- STEMI patient; Symptom onset in 12 hours; Intended to perform PPCI
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin Sodium InjectionHeparin Sodium Injection (100U/Kg body weight) | Drug | Administration of Heparin in Cathlab, Administration of Heparin in ER |
Primary outcome
The TIMI 3 flow of the infarct related artery before PPCI
Time frame: Coronary angiography, before PPCI，anticipated within 2 hours after randomization
The TIMI 3 flow of the infarct related artery at diagnostic angiography before PPCI
3 secondary outcomes
Major adverse cardiovascular or cerebrovascular event
Time frame: 30 day and 1 year after randomization
Major bleeding
Time frame: 30 day after randomization
Complete epicardial and myocardial reperfusion after PPCI
Time frame: within 90min after PPCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
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ST Elevation Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Chen, PhD principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin Sodium Injection in people with STEMI and Primary PCI, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The TIMI 3 flow of the infarct related artery before PPCI (time frame: Coronary angiography, before PPCI，anticipated within 2 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.