NCT07761455Not yet recruiting
Prophylactic IABP in Delayed-Presentation Anterior STEMI
Prophylactic Intra-Aortic Balloon Counterpulsation for Delayed-Presentation Anterior ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial (PROACTIVE-AMI)
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 504 (estimated)
- First submitted
- 1 Aug 2026
- Start date
- Aug 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Coronary artery disease
- NCT number
- NCT07761455
What you commit to
- Study type: Interventional
- Planned participants: 504
- From Aug 2026 to the primary completion date, Jan 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior coronary artery bypass grafting (CABG).
- Received thrombolytic therapy for this episode.
Other illness
- 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.
- Contraindications to IABP (severe peripheral vascular disease, aortic dissection, known aortic aneurysm, moderate-to-severe aortic regurgitation).
- 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.
Lab values
- 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).
- Prior myocardial infarction or known chronic heart failure (left ventricular ejection fraction \< 50%).
- 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.
Other
- Severe mechanical complications (e.g., free wall rupture, ventricular septal defect, acute severe mitral regurgitation).
- Initiation of any mechanical circulatory support (IABP, Impella, ECMO) before coronary angiography.
- Pregnancy or lactation.
- Currently participating in another interventional trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Qilu Hospital of Shandong University, Jinan, Shandong, China Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jining No. 1 People's Hospital. Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.