Cardiology clinical trials

Study to investigate CSL112 in Subjects with Acute Coronary Syndrome (AEGIS-II)

This study is currently recruiting participants.

Primary Objective: This is a phase 3 multicentre, double blinded, randomised, placebo-controlled study designed to evaluate the efficacy and safety of CSL112 on reducing the risk of MACE in patients with Acute Coronary Syndrome.  17,000 patients to be enrolled worldwide.

Principal Investigator: Dr Scott Harding

Study Coordinator: Donna Wylie

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03473223

New Zealand wide acute coronary syndrome audit (MOH)

This project is currently active.

Clinical Director: Alex Sasse

Study Coordinators: Beverley Scott/ Donna Wylie

Cardiac resynchronisation therapy and AV nodal ablation trial in atrial fibrillation

This study is currently recruiting participants.

Primary Objective: In the current study, we aim to test the hypothesis that ablating the AV node, which controls electrical conduction from the heart's atria (top chamber) to its ventricles (lower chambers), will improve survival and heart failure symptoms in CRT patients with co-existent AF. The results are important, because they will provide a way of passing on the benefits of CRT, such as improved survival, less heart failure symptoms, and better quality of life, to heart failure patients who also suffer from AF.

Principal Investigator: Matthew Webber

Study Coordinators: Bronwyn Davies/ Beverley Scott

Trial Website: https://clinicaltrials.gov/ct2/show/NCT01522898

Bempedoicacid in patients with high risk cardiovascular disease, who are statin intolerant

This study is currently recruiting participants.

Primary Objective: The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients who are statin intolerant.

Principal Investigator: Dr Scott Harding

Study Coordinator: Beverley Scott/ Bronwyn Davies

Trial Website: https://clinicaltrials.gov/ct2/show/NCT02993406

Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population with a Recent ACSThis study is in follow-up.

Primary Objective: A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile.

Principal Investigator: Dr Scott Harding

Study Coordinator: Beverley Scott

Trial Website: https://clinicaltrials.gov/ct2/show/NCT02525939

Evaluation of a Novel, Thin Strut Metallic Device: The Elixir DynamX Sirolimus Eluting Coronary Bioadaptor System

This study is currently recruiting participants.

Primary Objective: To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor System (SECBS) in de novo native coronary artery lesions using clinical and imaging endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months. Imaging follow-up will be conducted at 6 months.

Principal Investigator: Dr Scott Harding

Study Coordinator: Diane Middleditch

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03634020

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure with Iron Deficiency

This study is currently recruiting participants.

Primary Objective: The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction.

Principle Investigator: Dr Scott Harding

Study Coordinators: Beverley Scott/ Bronwyn Davies

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03037931

Optical Coherence Tomography (OCT) Guided Coronary Stent Implantation Compared to Angiography: a Multicentre Randomised Trial in PCI.

This study is currently recruiting participants.

Primary Objective: The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions. 3656 Patients Worldwide to be followed for 2 years.

Principal Investigator: Dr Scott Harding

Study Coordinator: Diane Middleditch

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03507777

A Randomised Controlled Trial with Resolute Onyx in One Month DAPT for High-Bleeding Risk Patients.

This study is in follow-up.

Primary Objective: To evaluate the Clinical Safety of the Resolute Onyx Stent as compared to the Biofreedom Stent with the use of One Month DAPT in Subjects deemed at High Risk for Bleeding and/or Medically Unsuitable for more than One Month DAPT Treatment. 2000 Patients Worldwide to be followed for 2 Years.

Principle Investigator: Dr Scott Harding

Study Coordinator: Diane Middleditch

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03344653

Inflammation genetics and risk following Myocardial Infarction

This study is in follow-up.

Study Coordinator: Bronwyn Davies/ Donna Wylie

Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction

This study is currently recruiting participants.

Primary Objective: The PROTECT-ICD trial is a physician-led, multi-centre randomised controlled trial targeting prevention of sudden cardiac death in patients who have poor cardiac function following a myocardial infarct (MI). The trial aims to assess the role of electrophysiology study (EPS) in guiding implantable cardioverter-defibrillator (ICD) implantation, in patients early following MI (first 40 days). The secondary aim is to assess the utility of cardiac MRI (CMR) in analysing cardiac function and viability as well as predicting inducible and spontaneous ventricular tachyarrhythmia when performed early post MI.

Principal Investigator: Matthew Webber

Study Coordinator: Beverley Scott

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03588286