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Prophylactic IABP in Delayed-Presentation Anterior STEMI

ConditionAcute Anterior ST-Segment Elevation Myocardial Infarction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intra-Aortic Balloon Pump

    Device

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

  • Primary Percutaneous Coronary Intervention

    Procedure/Surgery

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

Treatment groups

504 Participants
are divided into 2 treatment groups
Group A: Prophylactic IABP + PPCIExperimental treatment 2 interventions
Group B: Standard PPCI AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

180-day Major Adverse Cardiovascular Events (MACE)

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

Time frame
180 days

Secondary outcomes

1

All-cause Death

Death from any cause assessed at 180 days.

Time frame
180 days
2

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.

Time frame
180 days
3

Heart Failure

New-onset or worsening heart failure during hospitalization or rehospitalization after discharge for heart failure, assessed at 180 days.

Time frame
180 days
4

Cardiac Death

Death due to cardiovascular causes assessed at 180 days.

Time frame
180 days

Other outcomes

1

Major Bleeding

Safety Outcome Measures: Bleeding events classified as BARC 3-5, assessed at 30 days.

Time frame
30 days
2

Vascular Complications

Safety Outcome Measures: Severe vascular complications requiring surgical or endovascular repair, including limb ischemia, pseudoaneurysm, or arterial dissection, assessed at 30 days.

Time frame
30 days
3

Thrombocytopenia

Safety Outcome Measures: Platelet count \<100 × 10\^9/L or a decrease of \>50% from baseline, assessed at 30 days.

Time frame
30 days
4

Stroke

Safety Outcome Measures: Ischemic or hemorrhagic stroke adjudicated by the Clinical Events Committee, assessed at 30 days.

Time frame
30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Hospital of Shandong University

Lead sponsor

Source ClinicalTrials.gov

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