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Prophylactic IABP in Delayed-Presentation Anterior STEMI

NCT07761455 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2026-08-12

No results posted yet for this study

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

Interventions

DEVICE

Intra-Aortic Balloon Pump

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

PROCEDURE

Primary Percutaneous Coronary Intervention

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

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Yuguo Chen · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-01-31
Completion
2028-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761455 on ClinicalTrials.gov