Eclipse Study
Abbott - FreeDM2
CORE Study
A Randomised, Double-blind, Placebo-controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to patients with severe Hypertriglyceridemia. Sponsor: Ionis Pharmaceuticals, Inc.
The purpose of the study is to evaluate the efficacy of Olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
This is a multi-centre, randomized, double-blind, placebo-controlled study in up to approximately 540 participants. Participants will be randomized to receive Olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.
Recruitment – Closed to recruitment
Lead research staff contact for this study
Sarah Orr
Principal Investigator
Dr Patrick Moore
VENUS
This study is being carried out by to investigate and compare the use of different compression therapy in treating venous leg ulcers.
Venous leg ulcers are common a common problem and can often be recurring, presenting as open wounds on the lower leg. Compression is the first line of treatment for venous leg ulcers. A range of compression therapies such as four-layer bandages, two- layer hosiery, two-layer bandages and compression wraps are regularly used in the NHS.
- 1. Compression wraps (adjustable hook-and-loop-fastened compression): A compression sleeve around the foot and leg
- 2. Four-layer bandage or two-layer compression hosiery: If you are allocated to this treatment group, you and your healthcare professional will decide which treatment you receive. This will be either four layers of compression bandages or two layers of compression stockings
- 3. Two-layer compression bandage: this bandage will comprise of an initial bandage layer with a top compression bandage
We are conducting this study because we are unsure whether one compression therapy is more effective at treating venous leg ulcers than the others. To find the answer to this question, VenUS 6 will recruit and gather important information from a large number of people with a venous leg ulcer(s).
Recruitment – Closed to Recruitment
Lead research staff contact for this study – Wendy Higson & Brenda Furlong
Additional Information
- https://www.nhs.uk/conditions/leg-ulcer
- https://legsmatter.org/help-information/resources-for-healthcare-professionals/guide-for-leg-ulcer-compression-therapy
- https://bnf.nice.org.uk/wound-management/compression-hosiery-and-garments.html
ZEUS
This study is a multinational study by the pharmaceutical company Novo Nordisk, planned recruitment worldwide is 6200, we are looking for about 12 participants. The study drug is called Ziltevekimab, this is an antibody that targets and neutralises inflammation. It is known that inflammation leads to a build-up of fat in the blood vessels. The study is to test if Ziltivekimab can reduce the risk of future cardiovascular events.
The target population is those participants that are high risk of having further cardiovascular events, we are looking for participants with evidence of atherosclerotic cardio vascular disease within the last 5 years. Examples are:
- Myocardial infarction
- Stenosis of major coronary artery
- Stroke of atherosclerotic origin
- Peripheral arterial disease
- Intermittent claudication
- Lower amputation due to atherosclerotic disease
The study can last for up to 4 years.
Recruitment – Closed to recruitment
Lead research staff contact for this study – Sally Bradfield, Tracey Dare & Rebecca Cutts
ATTACK
This study is being carried out by The British heart Foundation and the National Institute for Health Research (NIHR) to test the hypothesis that the addition of 75mg aspirin once daily to usual care reduces the risk of major vascular events in patients with chronic kidney disease (CKD) who do not have pre-existing cardiovascular disease (CVD) .
CKD is common, particularly in older people and ranges from mild, moderate to severe. People who have mild to moderate disease may not even be aware as it doesn’t cause any outward symptoms. However, having CKD is significant because we know that it will increase the risk of developing cardiovascular disease leading to events like heart attacks and strokes later in life.
At present, people who have CKD and who have established cardiovascular disease and have already had a heart attack or stroke, will be prescribed aspirin to help prevent a further episode (this is called “secondary prevention”). However, we don’t yet have evidence to prove that if you have CKD and have not had a heart attack or stroke, that taking aspirin as a preventative measure (this is called “primary prevention”) can offset this risk.
This study will look at whether the taking 75mg aspirin daily (in addition to usual care) reduces risk of major vascular events in people with CKD who do not have pre-existing CVD, and whether and to what extent the benefits outweigh any harms due to increased risk of bleeding.
A positive result from ATTACK will help prevent around 50,000 major vascular events (i.e heart attack or stroke) across the UK over a 5-year period. However, a negative trial result provides definitive evidence to stop aspirin in 1 million people currently taking it for primary prevention of CVD.
Recruitment – 25,000 people will be recruited into this study across the UK. Half of the participants in the trial will be randomised to a daily prescription of Aspirin 75mg daily and half will be randomised to usual care (no aspirin).
Recruitment – CLOSED to recruitment.
Lead research staff contact for this study – Tracey Dare
Principle Investigator for this study – Dr Benjamin Oxley
Additional Information
https://www.southampton.ac.uk/attack-trial/information-for-patients.page
Trimaximise This is an observational study for patients over the age of 18years, with a confirmed diagnosis of asthma and who are prescribed an inhaler called “Trimbow”.
Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium),a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone). Trimbow MS (medium strength) contains 100 μg beclomethasone whereas Trimbow HS (high strength) contains 200 μg beclometasone. Both formulations are investigated in this study.
Trimbow has shown major clinical benefits in randomised controlled trials. However, the effects of Trimbow on changes in patients’ symptom burden and quality of life, adherence and clinical outcomes have not been assessed yet in a real-world asthma patient population.
This non-interventional study aims to collect prospective, longitudinal data from asthma patients under routine care, for whom the treating physician has decided to prescribe Trimbow MS (medium strength) or Trimbow HS (high strength) as per its current authorised indication. Aspects of adherence to Trimbow will be collected to gather knowledge on whether a single-inhaler triple therapy will lead to greater adherence and better clinical outcomes.
The study will collect data every 3 months. Total study participation will be 1 year.
Recruitment – Closed to Recruitment
Planned recruitment 3950 patients Europe wide.
200 patients from the UK.
Lead research staff contacts for this study– Rebecca Cutts and Brenda Furlong
Principle Investigator for this study– Dr Patrick Moore and Dr Benjamin Oxley
Additional information links/ hyperlinks
https://clinicaltrials.gov/ct2/show/NCT04902573
VESALIUS-CV
This study is being carried out by a commercial company called Amgen to investigate and compare the use of a monoclonial antibody injection called Repatha versus placebo.
The purpose of this study is to evaluate a cholesterol medication called “evolocumab” (“Repatha”) in reducing risk for major cardiovascular events (for example, heart attack or stroke). A lot of people already take cholesterol lowering medication called a statin but sometimes, despite this, the cholesterol in the blood stream remains high and this increases risk of cardiovascular events later in life.
Repatha works in a different way to statins. Statins help stop your liver from making as much cholesterol. Repathahelps the liver to clear bad cholesterol by limiting the actions of a protein called PCSK9, which means less bad cholesterol in your blood stream. If enrolling for the study, you would still need to take to statins. The study is “blinded” which means you would not know if you were prescribed the Repatha or a placebo.
A total of about 12,000 people are expected to participate in this study, out of which, approximately 1,200 participants will be enrolled from the UK. This study will take place in approximately 900 centres globally.
Recruitment – Closed to recruitment as of Dec 2021
Lead research staff contact for this study – Tracey Dare
Principle Investigator/ Sub Principle Investigator for this study – Dr Patrick Moore & Dr Benjamin Oxley
Additional Information
- https://www.clinicaltrials.gov/ct2/show/NCT03872401
- https://www.amgen.com/newsroom/press-releases/2021/08/new-data-at-esc-congress-2021-shows-repatha-evolocumab-improves-features-of-plaque-stability-in-patients-with-acute-coronary-syndrome-acs
Victor Study
Chronic Heart Failure (CHF) is a condition where the pumping ability of the heart is impaired. There can be may different causes of heart muscle weakening and symptoms can include breathlessness, fatigue and fluid retention. We already know that this can be managed effectively with different types of medications that prevent further weakening and strain on the heart (for example angiotensin converting enzyme inhibitors (“ACE” inhibitors), Beta blockers to name a few).
This trial is studying an investigational drug (MK-1242, also called vericiguat) to see if it can treat a type of heart failure where the heart has less strength than normal to pump blood to the body. You may be able to join this trial if you have chronic heart failure and have not had a recent worsening of your heart failure.
Vericiguat has been approved for treating some types of heart failure, but not for the type of heart failure that people in this trial have.
This trial is being done to:
• Test the safety and tolerability of vericiguat compared to placebo
• See if taking vericiguat lowers the chances of being hospitalised with worsening heart failure compared to placebo when added to your existing heart failure treatment
• See if vericiguat lowers the chances of dying from cardiovascular causes (heart and blood vessel) compared to placebo when added to your existing heart failure treatment
People in this trial will be randomly assigned (like flipping a coin) to take vericiguat or a placebo. A placebo is a look-alike pill that contains no real, active medicine. You will also continue to take your current medicines for heart failure during the trial.
The investigational drug is a tablet taken by mouth once a day.
While voluntary, if you join, you will be in this trial for about 2 years.
You will be able to stay on your current heart failure medications during the trial.
You can change your mind and stop taking part in the trial for any reason at any time. There is no cost to be in this trial and reasonable travel expenses will be reimbursed.
Recruitment – Closed to recruitment
The trial is recruiting from around the world in 34 countries and aiming to recruit around 6000 patients.
Lead research staff contact for this study
Tracey Dare
Helen Smith
Sally Bradfield
Principal Investigator
Dr Patrick Moore
Additional Information/ Hyperlinks https://www.merck.com/news/merck-announces-initiation-of-phase-3-study-evaluating-verquvo-vericiguat-in-patients-with-chronic-heart-failure-and-reduced-ejection-fraction-who-have-not-had-a-recent-worsening-heart-failure/
If you would like to know more please contact us by telephone or e mail: Research Team Voicemail 01202 339050 [email protected]
Additional Information