Early unfractionated heparin treatment in patients with STEMI - trial design and rationale

• Published in: PloS one Vol. 19; no. 5; p. e0303376
• Main Authors: Fister, Misa, Mikuz, Ursa, Ziberna, Klemen, Franco, Danilo, Radsel, Peter, Bunc, Matjaz, Noc, Marko, Goslar, Tomaz
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 09.05.2024; Public Library of Science (PLoS)
• Subjects: Adult; Aged; Angiography; Anticoagulants; Anticoagulants - administration & dosage; Anticoagulants - therapeutic use; Biology and Life Sciences; Care and treatment; Clinical trials; Comparative analysis; Coronary Angiography; Coronary artery; Diagnosis; Dosage and administration; Drug therapy; Emergency medical care; Eptifibatide; Female; Health aspects; Heart attack; Heart attacks; Hemodynamics; Heparin; Heparin - administration & dosage; Heparin - therapeutic use; Humans; Intensive care; Male; Medical imaging; Medical research; Medicine and Health Sciences; Medicine, Experimental; Middle Aged; Mortality; Myocardial infarction; Patient outcomes; Patients; People and Places; Percutaneous Coronary Intervention; Population studies; Reperfusion; Research and Analysis Methods; Shock; ST Elevation Myocardial Infarction - diagnostic imaging; ST Elevation Myocardial Infarction - drug therapy; Study Protocol; Thrombolysis; Transluminal angioplasty; Treatment Outcome; Troponin I; Italy; Europe; Slovenia
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0303376

The early unfractionated heparin (UFH) treatment in patients with ST-elevation myocardial infarction (STEMI) is a single-center, open-label, randomized controlled trial. The study population are patients with STEMI that undergo primary percutaneous coronary intervention (PPCI). The trial was designed to investigate whether early administration of unfractionated heparin immediately after diagnosis of STEMI is beneficial in terms of patency of infarct-related coronary artery (IRA) when compared to established UFH administration at the time of coronary intervention. The patients will be randomized in 1:1 fashion in one of the two groups. The primary efficacy endpoint of the study is Thrombolysis in myocardial infarction (TIMI) flow grades 2 and 3 on diagnostic coronary angiography. Secondary outcome measures are: TIMI flow after PPCI, progression to cardiogenic shock, 30-day mortality, ST-segment resolution, highest Troponin I and Troponin I values at 24 hours. The safety outcome is bleeding complications. The study of early heparin administration in patients with STEMI will address whether pretreatment with UFH can increase the rate of spontaneous reperfusion of infarct-related coronary artery.