BIC-8 Interventional Trial

bic-8-interventional-trial

The Biomarkers in Cardiology (BIC)-8 study is the first interventional clinical trial in the cardiac biomarker field and it confirms the safety and efficacy of the combined use of Copeptin and Troponin in patients with ACS.

BIC-8 results

Combined Copeptin/Tn results allow confident AMI rule-out, according to a “seminal” Ref-1 new 902-patient, multicenter, multinational, prospective, randomized, controlled study Ref-2, Biomarkers In Cardiology-8 (BIC-8). In BIC-8, the combined Copeptin-Troponin strategy:

  • Achieved a 5.6-fold increase in ED discharge rate: 67.6% in the Copeptin arm vs. 12.0% in the conventional arm (P <0.001)
  • Achieved a >40% reduction in hospital length-of-stay: median 4 hr in the Copeptin arm vs. 7 hr in the conventional arm (P <0.001)
  • Achieved a >40% reduction in ED/CPU length-of-stay in patients not admitted to wards or intensive care units, shortening the patient’s time in ED by 3 hours: median 4 hr in the Copeptin arm (n = 384) vs. 7 hr in the conventional arm (n = 383) (P <0.001)
  • Preserved safety:
    • 30-day major adverse cardiovascular event (MACE) (The BIC-8 study defined major cardiovascular adverse events as any of death from any cause, survived sudden cardiac arrest, re-hospitalization for acute coronary syndrome (ACS) acute unplanned percutaneous coronary intervention (PCI) coronary artery bypass grafting (CABG) documented life-threatening arrhythmias.) rate in the Copeptin arm was low and non-inferior to that of the conventional arm (image below):
    • Intention-to-treat analysis: 5.19% vs. 5.17%
    • Per-protocol analysis: 3.01% vs. 5.34%
      • No 30-day mortality occurred in the Copeptin arm

 

Download BIC-8 interventional trial

More information about the BIC-8 study in: BIC-8 Study summary (PDF)

safety-copeptin-troponinPreserved safety with the combined Copeptin-Troponin concept

 

References BIC-8 interventional trial

Ref-1: Mockel M, Searle J, Hamm C et al. Early discharge using single cardiac Troponin and Copeptin testing in patients with suspected acute coronary syndrome (ACS): a randomized, controlled clinical process study. Eur Heart J 2014: DOI: 10.1093/eurheartj/ehu178

Ref-2: Gandhi PU, Januzzi JL, Jr. Can Copeptin emerge from the growing shadow of the Troponins? Eur Heart J 2014: DOI: 10.1093/eurheartj/ehu211

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