{"id":"55677038533e","type":"article","url":"https://hartvaat.nl/2016/02/02/ciclosporine-a-bij-gereperfuseerd-myocardinfarct-de-multicenter-cycle-trial/","title":"Ciclosporine A bij gereperfuseerd myocardinfarct: de multicenter CYCLE-trial","title_en":"Cyclosporine A in Reperfused Myocardial Infarction: The Multicenter, Controlled, Open-Label CYCLE Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":["myocardinfarct"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2015.10.081","source_url":"https://doi.org/10.1016/j.jacc.2015.10.081","authors":["Filippo Ottani","Roberto Latini","Lidia Staszewsky","Luigi La Vecchia","Nicola Locuratolo","Marco Sicuro","Serge Masson","Simona Barlera","Valentina Milani","Mario Lombardi","Alessandra Costalunga","Nadia Mollichelli","Andrea Santarelli","Nicoletta De Cesare","Paolo Sganzerla","Alberto Boi","Aldo Pietro Maggioni","Ugo Limbruno"],"significance":6,"published":"2016-02-02","source_date":"2016-02-02","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/revalidatie-na-hartinfarct/"],"congress":"","summary_en":"The CYCLE trial showed that cyclosporine A did not improve ST-segment resolution in patients with reperfused myocardial infarction, adding to the neutral evidence for mitochondrial permeability transition pore inhibition as a cardioprotective strategy.","created":"2026-07-03T10:25:56Z","updated":"2026-07-03T13:25:18Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde multicenter fase-II-studie die onderzocht of ciclosporine A de ST-segmentresolutie verbetert bij gereperfuseerd myocardinfarct. Onderzoekt het concept van reperfusieschadebeperking.","abstract_original":"BACKGROUND: Whether cyclosporine A (CsA) has beneficial effects in reperfused myocardial infarction (MI) is debated. OBJECTIVES: This study investigated whether CsA improved ST-segment resolution in a randomized, multicenter phase II study. METHODS: The authors randomly assigned 410 patients from 31 cardiac care units, age 63 ± 12 years, with large ST-segment elevation MI within 6 h of symptom onset, Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1 in the infarct-related artery, and committed to primary percutaneous coronary intervention, to 2.5 mg/kg intravenous CsA (n = 207) or control (n = 203) groups. The primary endpoint was incidence of ≥70% ST-segment resolution 60 min after TIMI flow grade 3. Secondary endpoints included high-sensitivity cardiac troponin T (hs-cTnT) on day 4, left ventricular (LV) remodeling, and clinical events at 6-month follow-up. RESULTS: Time from symptom onset to first antegrade flow was 180 ± 67 min; a median of 5 electrocardiography leads showed ST-segment deviation (quartile [Q]1 to Q3: 4 to 6); 49.8% of MIs were anterior. ST-segment resolution ≥70% was found in 52.0% of CsA patients and 49.0% of controls (p = 0.55). Median hs-cTnT on day 4 was 2,160 (Q1 to Q3: 1,087 to 3,274) ng/l in CsA and 2,068 (1,117 to 3,690) ng/l in controls (p = 0.85). The 2 groups did not differ in LV ejection fraction on day 4 and at 6 months. Infarct site did not influence CsA efficacy. There were no acute allergic reactions or nonsignificant excesses of 6-month mortality (5.7% CsA vs. 3.2% controls, p = 0.17) or cardiogenic shock (2.4% CsA vs. 1.5% controls, p = 0.33). CONCLUSIONS: In the CYCLE (CYCLosporinE A in Reperfused Acute Myocardial Infarction) trial, a single intravenous CsA bolus just before primary percutaneous coronary intervention had no effect on ST-segment resolution or hs-cTnT, and did not improve clinical outcomes or LV remodeling up to 6 months. (CYCLosporinE A in Reperfused Acute Myocardial Infarction [CYCLE]; NCT01650662; EudraCT number 2011-002876-18)."}