Prophylactic IABP in Delayed-Presentation Anterior STEMI
Condition(s) studied
Investigational drug(s) / intervention(s)
Intra-Aortic Balloon Pump: Intra-aortic balloon counterpulsation initiated before opening the infarct-related artery and maintained according to protocol.
Primary Percutaneous Coronary Intervention: Standard primary percutaneous coronary intervention for infarct-related artery reperfusion.
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.
Eligibility
Primary outcome measure(s)
- 180-day Major Adverse Cardiovascular Events (MACE) — 180 days
Composite of all-cause death, cardiogenic shock and heart failure assessed at 180 days.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Qilu Hospital of Shandong University, Jinan, Shandong, China | Jinan | Shandong | |
| Jining No.1 People's Hospital | Jining | Shandong | |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | |
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | China |
More Qilu Hospital of Shandong University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07761455 on ClinicalTrials.gov ↗ ← All trials in China