Clinical development based on scientific experience
and sophisticated methodologies

Clinical trials

The Bulgarian Cardiac Institute, in collaboration with the pharmacological industry, takes an active part in the clinical development of medicine through healthcare data evaluation, innovative healthcare technologies, improved methodology and clinical experience.

All clinical trials are performed according to the European and Bulgarian legislation requirements and the good clinical practice.

Completed and ongoing randomized clinical trials in the Bulgarian Cardiac Institute:

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  • ODDYSSEY – randomized, double blind, placebo controlled clinical trial with parallel groups to evaluate the effect of  SAR236553/REGN727 (alirocumab) on the cardiovascular events in patients with acute coronary syndrome
  • MEIN/10/RAN-CAD/003 – randomized, double blind, placebo controlled clinical trial with parallel groups to evaluate the efficacy of ranolazine in patients with coronary artery disease
  • PIONEER AF-PCI – randomized, open, controlled, multi center clinical trial, evaluating two treatment strategies with rivaroxaban, and strategy with Vit. K antagonist (with dose adjustment) in patients after coronary artery intervention
  • SPIRE-FH – randomized, double blind, placebo controlled clinical trial with parallel groups to evaluate the efficacy, safety and tolerance of  PF-04950615; RN316 (bococizumab) for treatment of patients with familial heterozygotic hypercholesterolemia
  • RE-DUAL PCI – randomized, prospective, open, with blinded endpoint (PROBE) clinical trial for evaluation of double antithrombotic therapy with dabigatran etexilate plus clopidogrel or  ticagrelor compared with triple therapy warfarin with clopidogrel or ticagrelor and acetylsalicylic acid in patients with non-valvular atrial fibrillation (NVAF), after percutaneous coronary intervention with stent implantation
  • ЕNSURE-AF- randomized, prospective, open clinical trial with parallel groups with blinded end point (PROBE) for comparison of edoxaban (DU-176b) with enoxaparin/warfarin, followed by a single warfarin application in patients after planned electrical cardioversion in non-valvular atrial fibrillation
  • AEGIS-I – randomized, multi center, placebo-controlled with varying dose clinical trial for evaluation of safety and tolerance of multiple CSL112 applications in patients with myocardial infarction
  • MARINER – randomized, multi center, placebo controlled clinical trial for evaluation of rivaroxaban in risk lowering for venous thromboembolism after a hospital treatment of clinically diagnosed patients
  • GEMINI ACS1 – randomized, double blinded, active controlled with parallel groups, multi center clinical trial for comparison of safety of rivaroxaban with acetylsalicylic acid in addition to clopidogrel or ticagrelor in patients with acute coronary syndrome.
  • DU176b-C-Е314 – randomized with parallel groups, multi center clinical trial for evaluation of  edoxaban in anticoagulants naive patients with non-valvular atrial fibrillation with elevated creatinine clearance
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  • CV185-316 – randomized, open, 2 x 2 controlled clinical trial for evaluation of safety of apixaban vs vit K antagonist and acetylsalicylic acid, compared with placebo and acetylsalicylic acid, in patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention
  • NOAH-AFNET6 – randomized, double blind, controlled clinical trial, evaluating the use of oral anticoagulants or Vit. K antagonists in patients with high percentage of atrial fibrillation
  • PANTHEON – randomized, multi center, placebo controlled with parallel groups, double blind clinical trial for evaluation of the efficacy, safety, pharmacokinetic and pharmacodynamics effects of oral adenosin A1 receptor antagonist (neladenoson bialanate) for 20 weeks in patients with chronic heart failure and reduced ejection fraction
  • PROMINENT – randomized, placebo controlled, blinded clinical trial, for evaluation of pemafibrate for cardiovascular events reduction through triglycerides lowering in patients with diabetes.
  • CHAMPION PHOENIX – randomized, controlled, double blinded clinical trial for evaluation cangrelor with clopidogrel in patients with percutaneous coronary interventions
  • ТАО- randomized, double blind, controlled, multi center clinical trial, for evaluation of efficacy of otamixaban with unfractionated heparin plus eptifibatide in patients with unstable angina pectoris or NSTEMI and early invasive evaluation
  • CLEAR Outcomes- randomized, double blind, parallel, placebo-controlled clinical trial, for evaluation efficacy of bempedoic acid for serious cardiovascular events in patients with cardiovascular diseases
  • GLORIA-AF- prospective, clinical trial for efficacy follow up of anti-thrombotic therapy in atrial fibrillation patients
  • APEX – randomized, double blind, parallel, multi center clinical trial, evaluating efficacy and safety of betrixaban long term use for venous thromboembolism prevention in patients with diseases in acute phase
  • PRAGUE-13 – multi center, controlled clinical trial, evaluating two treatment strategies for patients with acute myocardial infarction with ST- elevation (STEMI), which have at least one significant stenosis of other vessels – complete revascularisation vs conservative treatment.
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