Prophylactic IABP in Delayed-Presentation Anterior STEMI

NCT07761455 | Not Yet Recruiting DMC

• 1 other identifier: KYLL-2026-04-009-2
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 4

Brief 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 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.

Conditions

Acute Anterior ST-Segment Elevation Myocardial Infarction

Keywords

STEMI; Anterior myocardial infarction; Delayed presentation; Intra-aortic balloon pump; IABP; Primary PCI; Percutaneous coronary intervention; Mechanical circulatory support

Outcome Measures

Primary Outcomes (1)

• 180-day Major Adverse Cardiovascular Events (MACE)

  Composite of all-cause death, cardiogenic shock and heart failure assessed at 180 days.

  180 days

Secondary Outcomes (11)

• All-cause Death

  180 days

• Cardiogenic Shock

  180 days

• Heart Failure

  180 days

• Cardiac Death

  180 days

• Length of Hospital Stay

  from admission to discharge

Other Outcomes (4)

• Major Bleeding

  30 days

• Vascular Complications

  30 days

• Thrombocytopenia

  30 days

Study Arms (2)

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.

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.

Procedure: Primary Percutaneous Coronary Intervention

Interventions

Intra-Aortic Balloon Pump DEVICE

Intra-aortic balloon counterpulsation initiated before opening the infarct-related artery and maintained according to protocol.

Prophylactic IABP + PPCI

Primary Percutaneous Coronary Intervention PROCEDURE

Standard primary percutaneous coronary intervention for infarct-related artery reperfusion.

Prophylactic IABP + PPCI; Standard PPCI Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%).
• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (4)

Qilu Hospital of Shandong University, Jinan, Shandong, China

Jinan, Shandong, 250012, China

Location

Jining No.1 People's Hospital

Jining, Shandong, 272011, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, 100037, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Anterior Wall Myocardial Infarction

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

Study Officials

• Yuguo Chen

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Chuanbao Li, MD

CONTACT

+86 18560083097; lichuanbao@qiluhospital.cn

Yuguo Chen, MD

CONTACT

+86 18560085555; chen919085@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The trial is open-label for participants and treating clinicians. Primary and key secondary outcomes will be adjudicated by an independent Clinical Events Committee blinded to treatment assignment, and imaging analyses will be performed by a blinded core laboratory.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm, randomized, parallel-group clinical trial.

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)