CTU Bern (Clinical Trials Unit)

Cardiology Trials: Recruitment open!

Three cardiology trials started recruitment:

The High bleeding risk (HBR) patients undergoing PCI also frequently present risk factors of stent thrombosis and future athero-thrombotic events. Managing these patients in terms of decision on the most appropriate course of dual antiplatelet therapy (DAPT) after stent implantation remains a clinical challenge, especially after implantation of newer generation drug eluting stents (DES). The MASTER DAPT  is an Investigator-initiated, multi-center, randomized clinical trial in HBR patients after PCI with Ultimaster bioresorbable polymer coated sirolimus-eluting stent implantation.The aim of study is compare, within current guidelines (GL) and instructions for use (IFU), an abbreviated versus a prolonged DAPT duration after bioresorbable polymer coated Ultimaster sirolimus-eluting stent implantation in patients presenting HBR features. More information can be found here.

Hypercholesterolemia is a major risk factor for the development and progression of Coronary artery disease (CAD). HMG-CoA reductase inhibitors (statins) lower plasma levels of low-density lipoprotein cholesterol (LDL-C), and they reduce cardiovascular mortality in proportion to the magnitude of LDL-C lowering. While statins currently represent the first-line, gold-standard therapy for primary and secondary prevention of cardiovascular morbidity and mortality, nearly 50% of patients in Europe and Canada treated with statins do not achieve their target levels of LDL-C or cannot tolerate effective statin doses; subsequently, substantial LDL-associated residual risk remains. Experimental studies have demonstrated that proprotein convertase subtilisin/kexin type 9 (PCSK9) reduces the hepatic uptake of LDL-C by increasing the lysosomal degradation of LDL receptors. The PACMAN study aim to evaluate the Effects of the PCSK9 Antibody Alirocumab on Coronary Atherosclerosis in Patients with Acute Myocardial Infarction by means of Serial, Multivessel, Intravascular Ultrasound, Near-Infrared Spectroscopy And Optical Coherence Tomography Imaging.

The Symetis ACURATE neo/TF, a self-expandable transcatheter valve delivered via transfemoral access, gained CE mark approval in September 2014 after showing favorable procedural and short term results. The SCOPE I trial will compare its performance to the balloon-expandable Edwards SAPIEN 3, a widely used and well established transcatheter heart valve of the second generation, in a randomized fashion.

Two cardiology trials in 1 year follow up:

The 1 year follow up of BIOSTEMI study has started and will continue into 2018. Primary percutaneous coronary intervention (PCI) is considered nowadays as the reperfusion strategy of choice for patients with acute ST‐segment elevation myocardial infarction, owing to a lower risk of myocardial re‐infarction and improved short‐ and long‐term survival compared to fibrinolysis. However, STEMI is still associated with poorer clinical outcomes after PCI, compared to stable CAD (CAD), with higher rates of stent thrombosis and an increased risk myocardial re‐infarction persisting throughout long‐term follow‐up.The purpose of the study is to compare the safety and efficacy of a novel biodegradable‐polymer sirolimus‐eluting stent (Orsiro®) with a durable‐polymer everolimus‐eluting stent (Xience Xpedition or Xience Alpine®) in a superiority trial among patients presenting with acute STEMI and undergoing primary PCI. More information can be found here.

The 1 year follow up of MATRIX study was recently completed and analysis of the prolonged follow-up are underway. Bleeding in patients with acute coronary syndrome (ACS) is associated with an increased risk of long term mortality and morbidity, and this relationship is currently thought to be causal. Therefore' reducing the frequency of bleeding events while maintaining efficacy is an important goal in the management of patients with ACS. The most common site of bleeding in invasively managed patients with ACS is at the femoral artery puncture site used for heart catheterization. Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of AngioX (MATRIX) study intended to compare trans-radial versus trans-femoral intervention and bivalirudin monotherapy versus current European standard of care consisting of unfractionated heparin (UFH) plus provisional use of glycoprotein IIb/IIIa inhibition via the use of one of the three available agents on the market (e.g. abciximab, tirofiban or eptifibatide) in patients (≥18 years) with ACS, that are intended for an invasive management strategy. More information can be found at ScienceDirect or NCBI.