Acute Anterior ST-Segment Elevation Myocardial InfarctionPROACTIVE-AMINCT07761455
Prophylactic IABP in Delayed-Presentation Anterior STEMI
A study testing Intra-Aortic Balloon Pump and Primary Percutaneous Coronary Intervention in people with Acute Anterior ST-Segment Elevation Myocardial Infarction, run by Qilu Hospital of Shandong University at 4 sites in China.
Trial summary
PROACTIVE-AMI is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication evaluating whether prophylactic intra-aortic balloon counterpulsation (IABP) initiated before primary percutaneous coronary intervention (PPCI) improves clinical outcomes in patients with delayed-presentation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Anterior ST-Segment Elevation Myocardial Infarction
- What is being tested?
- Intra-Aortic Balloon Pump and Primary Percutaneous Coronary Intervention
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 4 sitesChina
- Study dates
- 1 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- First electrocardiogram on arrival shows ST-segment elevation ≥ 2 mm in at least two contiguous anterior leads, or sum of ST-segment elevation ≥ 4 mm in anterior leads.
- Ischemic symptoms (chest pain, chest tightness, upper abdominal discomfort, left shoulder radiation, etc.) onset to hospital arrival between ≥ 4 hours and ≤ 12 hours, and planned for primary PCI.
- Coronary angiography confirms the infarct-related artery is the proximal left anterior descending (LAD) (before the first septal branch or first diagonal branch) with TIMI flow grade 0 (total occlusion).
- Patient or legal representative provides written informed consent.
Who cannot join
- Established cardiogenic shock (systolic blood pressure < 90 mmHg without inotropes/vasopressors, or requiring vasopressors to maintain systolic blood pressure ≥ 90 mmHg, AND blood lactate > 2.0 mmol/L).
- Severe heart failure: Killip class ≥ III, or requiring non-invasive/invasive positive pressure ventilation before enrollment.
- Malignant arrhythmias, including cardiac arrest, ventricular fibrillation, ventricular flutter, pulseless ventricular tachycardia, or high-grade atrioventricular block.
- Severe mechanical complications (e.g., free wall rupture, ventricular septal defect, acute severe mitral regurgitation).
- Contraindications to IABP (severe peripheral vascular disease, aortic dissection, known aortic aneurysm, moderate-to-severe aortic regurgitation).
- Prior myocardial infarction or known chronic heart failure (left ventricular ejection fraction < 50%).
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- Prior coronary artery bypass grafting (CABG).
- Stroke within 1 month, or history of hemorrhagic stroke at any time.
- Active gastrointestinal bleeding within 3 months, or gastrointestinal diseases with increased bleeding risk.
- Received thrombolytic therapy for this episode.
- Initiation of any mechanical circulatory support (IABP, Impella, ECMO) before coronary angiography.
- Severe hepatic insufficiency (Child-Pugh C, or ALT >5×ULN with total bilirubin >3×ULN), renal insufficiency (eGFR < 15 mL/min/1.73 m² or chronic dialysis), or end-stage disease with life expectancy < 1 year.
- Pregnancy or lactation.
- Currently participating in another interventional trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, 100037
Qing Gu, MD, PhD, +86 10 88396009, guqingfw@126.com
Qilu Hospital of Shandong University, Jinan, Shandong, China
Jinan, Shandong, 250012
Chuanbao Li, MD, +86 18560083097, bao2460@126.com
Yuguo Chen, MD
Jining No.1 People's Hospital
Jining, Shandong, 272011
Daqing Song, MD, +86 537 2253115, songdq_jn@163.com
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Peng Li, MD, +86 532 82911101, lipeng_qdu@163.com
About this study
Official title: Prophylactic Intra-Aortic Balloon Counterpulsation for Delayed-Presentation Anterior ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial (PROACTIVE-AMI)
PROACTIVE-AMI is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication evaluating whether prophylactic intra-aortic balloon counterpulsation (IABP) initiated before primary percutaneous coronary intervention (PPCI) improves clinical outcomes in patients with delayed-presentation acute anterior ST-segment elevation myocardial infarction (STEMI). Eligible patients are adults aged ≥18 years who present 4 to 12 hours after symptom onset, have electrocardiographic evidence of anterior STEMI with proximal left anterior descending artery total occlusion (TIMI flow 0), and are planned for PPCI. Participants will be randomized 1:1 to pre-PPCI IABP plus standard PPCI or standard PPCI alone. The primary endpoint is 180-day major adverse cardiovascular events (MACE), defined as a composite of all-cause death, cardiogenic shock, and new or worsening heart failure. Secondary outcomes include individual MACE components, cardiac death, length of stay, NT-proBNP, left ventricular ejection fraction, and left ventricular end-diastolic volume. Safety outcomes include major bleeding, vascular complications, thrombocytopenia, and stroke.
Read the detailed description
This is a prospective, multicenter, randomized, open-label, parallel-group, controlled clinical trial with blinded endpoint adjudication. The study is designed to evaluate whether prophylactic intra-aortic balloon counterpulsation (IABP) before primary percutaneous coronary intervention (PPCI) can improve outcomes in patients with delayed-presentation acute anterior ST-segment elevation myocardial infarction (STEMI). Eligible patients are adults aged ≥18 years with symptom onset to presentation between 4 and 12 hours, electrocardiographic evidence of anterior STEMI (≥2 mm ST elevation in contiguous anterior leads or sum ≥4 mm), and angiographically confirmed proximal left anterior descending artery occlusion with TIMI flow 0. After informed consent and coronary angiography confirming eligibility, participants are randomized in a 1:1 ratio to one of two groups: (1) prophylactic IABP before infarct-related artery opening plus standard PPCI, or (2) standard PPCI alone. In the intervention group, IABP will be inserted before PCI, operated at a 1:1 counterpulsation ratio for at least 24 hours and up to 72 hours as clinically appropriate. In the control group, prophylactic mechanical circulatory support will not be routinely used; rescue IABP may be initiated if predefined hemodynamic deterioration or complications occur. All participants receive guideline-directed medical therapy for ST-segment elevation myocardial infarction. The primary endpoint is major adverse cardiovascular events (MACE) within 180 days after randomization, defined as a composite of all-cause death, cardiogenic shock, and new or worsening heart failure. Secondary endpoints include individual components of the primary composite endpoint, cardiac death, length of hospital stay, NT-proBNP at 90 and 180 days, left ventricular ejection fraction and left ventricular end-diastolic volume at 90 and 180 days. Safety outcomes include major bleeding (BARC 3-5), vascular complications, thrombocytopenia, and stroke within 30 days. Follow-up assessments will be performed during hospitalization and at 30, 90, and 180 days after randomization. Endpoint adjudication will be performed by an independent clinical events committee blinded to treatment assignment.
- Being tested
- Intra-Aortic Balloon Pump, Primary Percutaneous Coronary Intervention
- Keywords
- STEMI, Anterior myocardial infarction, Delayed presentation, Intra-aortic balloon pump, IABP, Primary PCI, Percutaneous coronary intervention, Mechanical circulatory support
- Medical subject headings
- ST Elevation Myocardial Infarction, Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Aortic Balloon PumpDevice
Intra-aortic balloon counterpulsation initiated before opening the infarct-related artery and maintained according to protocol.
Primary Percutaneous Coronary InterventionProcedure or surgery
Standard primary percutaneous coronary intervention for infarct-related artery reperfusion.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic IABP + PPCI | Experimental | Participants randomized to this arm will receive prophylactic intra-aortic balloon pump counterpulsation before primary percutaneous coronary intervention (PPCI), followed by standard PPCI and guideline-directed medical therapy. Receives: Device: Intra-Aortic Balloon Pump; Procedure: Primary Percutaneous Coronary Intervention |
| Standard PPCI Alone | Active comparator | Participants randomized to this arm will receive standard PPCI and guideline-directed medical therapy without routine prophylactic IABP. Rescue IABP may be used only if clinically indicated according to protocol. Receives: Procedure: Primary Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
180-day Major Adverse Cardiovascular Events (MACE)
Composite of all-cause death, cardiogenic shock and heart failure assessed at 180 days.
Measured: 180 days
Secondary outcomes (11)
All-cause Death
Death from any cause assessed at 180 days.
Measured: 180 days
Cardiogenic Shock
Cardiogenic shock defined as systolic blood pressure <90 mmHg without vasoactive support or requiring vasoactive agents to maintain blood pressure, together with blood lactate >2.0 mmol/L, assessed at 180 days.
Measured: 180 days
Heart Failure
New-onset or worsening heart failure during hospitalization or rehospitalization after discharge for heart failure, assessed at 180 days.
Measured: 180 days
Cardiac Death
Death due to cardiovascular causes assessed at 180 days.
Measured: 180 days
Length of Hospital Stay
Number of days from admission to discharge.
Measured: from admission to discharge
NT-proBNP
Plasma NT-proBNP level at 90 days.
Measured: 90 days
NT-proBNP
Plasma NT-proBNP level at 180 days.
Measured: 180 days
Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction assessed by echocardiography or other protocol-specified imaging modality at 90 days.
Measured: 90 days
Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction assessed by echocardiography or other protocol-specified imaging modality at 180 days.
Measured: 180 days
Left Ventricular End-Diastolic Volume (LVEDV)
Left ventricular end-diastolic volume assessed by echocardiography or other protocol-specified imaging modality at 90 days.
Measured: 90 days
Left Ventricular End-Diastolic Volume (LVEDV)
Left ventricular end-diastolic volume assessed by echocardiography or other protocol-specified imaging modality at 180 days.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Anterior ST-Segment Elevation Myocardial InfarctionStudies 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
- Model description
- This is a two-arm, randomized, parallel-group clinical trial.
- Masking
- None (open label)
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuguo Chen, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761455
- Sponsor's protocol ID
- KYLL-2026-04-009-2
- Acronym
- PROACTIVE-AMI
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study team does not currently have a data sharing plan or repository in place. De-identified participant-level data may be available from the corresponding author upon reasonable request and subject to institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Intra-Aortic Balloon Counterpulsation for Delayed-Presentation Anterior ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial (PROACTIVE-AMI)
- ClinicalTrials.gov ID
- NCT07761455
- Acronym / sponsor ID
- PROACTIVE-AMI / KYLL-2026-04-009-2
- Keywords
- STEMI, Anterior myocardial infarction, Delayed presentation, Intra-aortic balloon pump, IABP, Primary PCI, Percutaneous coronary intervention, Mechanical circulatory support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 12 Aug 2026 (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.
PROACTIVE-AMI is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication evaluating whether prophylactic intra-aortic balloon counterpulsation (IABP) initiated before primary percutaneous coronary intervention (PPCI) improves clinical outcomes in patients with delayed-presentation acute anterior ST-segment elevation myocardial infarction (STEMI). Eligible patients are adults aged ≥18 years who present 4 to 12 hours after symptom onset, have electrocardiographic evidence of anterior STEMI with proximal left anterior descending artery total occlusion (TIMI flow 0), and are planned for PPCI. Participants will be randomized 1:1 to pre-PPCI IABP plus standard PPCI or standard PPCI alone. The primary endpoint is 180-day major adverse cardiovascular events (MACE), defined as a composite of all-cause death, cardiogenic shock, and new or worsening heart failure. Secondary outcomes include individual MACE components, cardiac death, length of stay, NT-proBNP, left ventricular ejection fraction, and left ventricular end-diastolic volume. Safety outcomes include major bleeding, vascular complications, thrombocytopenia, and stroke.
Detailed description
This is a prospective, multicenter, randomized, open-label, parallel-group, controlled clinical trial with blinded endpoint adjudication. The study is designed to evaluate whether prophylactic intra-aortic balloon counterpulsation (IABP) before primary percutaneous coronary intervention (PPCI) can improve outcomes in patients with delayed-presentation acute anterior ST-segment elevation myocardial infarction (STEMI). Eligible patients are adults aged ≥18 years with symptom onset to presentation between 4 and 12 hours, electrocardiographic evidence of anterior STEMI (≥2 mm ST elevation in contiguous anterior leads or sum ≥4 mm), and angiographically confirmed proximal left anterior descending artery occlusion with TIMI flow 0. After informed consent and coronary angiography confirming eligibility, participants are randomized in a 1:1 ratio to one of two groups: (1) prophylactic IABP before infarct-related artery opening plus standard PPCI, or (2) standard PPCI alone. In the intervention group, IABP will be inserted before PCI, operated at a 1:1 counterpulsation ratio for at least 24 hours and up to 72 hours as clinically appropriate. In the control group, prophylactic mechanical circulatory support will not be routinely used; rescue IABP may be initiated if predefined hemodynamic deterioration or complications occur. All participants receive guideline-directed medical therapy for ST-segment elevation myocardial infarction. The primary endpoint is major adverse cardiovascular events (MACE) within 180 days after randomization, defined as a composite of all-cause death, cardiogenic shock, and new or worsening heart failure. Secondary endpoints include individual components of the primary composite endpoint, cardiac death, length of hospital stay, NT-proBNP at 90 and 180 days, left ventricular ejection fraction and left ventricular end-diastolic volume at 90 and 180 days. Safety outcomes include major bleeding (BARC 3-5), vascular complications, thrombocytopenia, and stroke within 30 days. Follow-up assessments will be performed during hospitalization and at 30, 90, and 180 days after randomization. Endpoint adjudication will be performed by an independent clinical events committee blinded to treatment assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, randomized, parallel-group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Prophylactic IABP + PPCI | Experimental | Device: Intra-Aortic Balloon Pump, Procedure: Primary Percutaneous Coronary InterventionParticipants randomized to this arm will receive prophylactic intra-aortic balloon pump counterpulsation before primary percutaneous coronary intervention (PPCI), followed by standard PPCI and guideline-directed medical therapy. |
| Standard PPCI Alone | Active comparator | Procedure: Primary Percutaneous Coronary InterventionParticipants randomized to this arm will receive standard PPCI and guideline-directed medical therapy without routine prophylactic IABP. Rescue IABP may be used only if clinically indicated according to protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- First electrocardiogram on arrival shows ST-segment elevation ≥ 2 mm in at least two contiguous anterior leads, or sum of ST-segment elevation ≥ 4 mm in anterior leads.
- Ischemic symptoms (chest pain, chest tightness, upper abdominal discomfort, left shoulder radiation, etc.) onset to hospital arrival between ≥ 4 hours and ≤ 12 hours, and planned for primary PCI.
- Coronary angiography confirms the infarct-related artery is the proximal left anterior descending (LAD) (before the first septal branch or first diagonal branch) with TIMI flow grade 0 (total occlusion).
- Patient or legal representative provides written informed consent.
Key exclusion criteria (14 listed)
- Established cardiogenic shock (systolic blood pressure < 90 mmHg without inotropes/vasopressors, or requiring vasopressors to maintain systolic blood pressure ≥ 90 mmHg, AND blood lactate > 2.0 mmol/L).
- Severe heart failure: Killip class ≥ III, or requiring non-invasive/invasive positive pressure ventilation before enrollment.
- Malignant arrhythmias, including cardiac arrest, ventricular fibrillation, ventricular flutter, pulseless ventricular tachycardia, or high-grade atrioventricular block.
- Severe mechanical complications (e.g., free wall rupture, ventricular septal defect, acute severe mitral regurgitation).
- Contraindications to IABP (severe peripheral vascular disease, aortic dissection, known aortic aneurysm, moderate-to-severe aortic regurgitation).
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 |
|---|---|---|
| Intra-Aortic Balloon PumpIntra-aortic balloon counterpulsation initiated before opening the infarct-related artery and maintained according to protocol. | Device | Prophylactic IABP + PPCI |
| Primary Percutaneous Coronary InterventionStandard primary percutaneous coronary intervention for infarct-related artery reperfusion. | Procedure or surgery | Prophylactic IABP + PPCI, Standard PPCI Alone |
Primary outcome
180-day Major Adverse Cardiovascular Events (MACE)
Time frame: 180 days
Composite of all-cause death, cardiogenic shock and heart failure assessed at 180 days.
11 secondary outcomes
All-cause Death
Time frame: 180 days
Cardiogenic Shock
Time frame: 180 days
Heart Failure
Time frame: 180 days
Cardiac Death
Time frame: 180 days
Length of Hospital Stay
Time frame: from admission to discharge
NT-proBNP
Time frame: 90 days
NT-proBNP
Time frame: 180 days
Left Ventricular Ejection Fraction (LVEF)
Time frame: 90 days
Left Ventricular Ejection Fraction (LVEF)
Time frame: 180 days
Left Ventricular End-Diastolic Volume (LVEDV)
Time frame: 90 days
Left Ventricular End-Diastolic Volume (LVEDV)
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study team does not currently have a data sharing plan or repository in place. De-identified participant-level data may be available from the corresponding author upon reasonable request and subject to institutional approval.
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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.
Yuguo Chen study chair
Qilu Hospital of Shandong University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Aortic Balloon Pump and Primary Percutaneous Coronary Intervention in people with Acute Anterior ST-Segment Elevation Myocardial Infarction, run by Qilu Hospital of Shandong University at 4 sites 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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuanbao Li, MD (+86 18560083097, lichuanbao@qiluhospital.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
180-day Major Adverse Cardiovascular Events (MACE) (time frame: 180 days). 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 12 Aug 2026.