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AZ’s THALES trial shows significant benefits for stroke patients

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Detailed results from a prespecified exploratory analysis of the positive THALES Phase III trial showed Brilinta (ticagrelor) 90mg, used twice daily and taken with daily aspirin for 30 days, reduced the rate of the composite of disabling stroke or death by 17% compared to aspirin alone; in patients who had an acute ischaemic stroke or transient ischaemic attack (TIA).

The rate of the composite of non-disabling stroke or death at 30 days was 1.3% in the aspirin plus ticagrelor group and 1.6% in the aspirin only group (HR 0.79 [95% CI 0.57, 1.08], p=0.140).

Following a recurrent stroke, patients treated with aspirin plus ticagrelor experienced a nominally significant reduction of disability burden compared to aspirin alone, based on an analysis of modified Rankin score (OR 0.77 [95%CI 0.65, 0.91], nominal p=0.002).

These new findings reinforce results of the Phase III THALES trial showing a statistically significant and clinically meaningful reduction in the composite of stroke or death at 30 days in patients with a stroke or TIA receiving aspirin plus ticagrelor versus aspirin alone.

Prof Pierre Amarenco, vice-chair of the THALES Executive Committee and Professor of Neurology at Paris University, said: “Until now, only aspirin had shown a significant reduction in disabling stroke during the first 90 days following an ischaemic stroke in a single trial. These new findings from THALES show that aspirin plus ticagrelor could provide a clinically meaningful reduction of the composite of disabling stroke and death compared to aspirin alone at day 30 due to subsequent ischaemic stroke.”

Dr Clay Johnston, chair of the THALES Executive Committee and Dean of the Dell Medical School at The University of Texas in Austin, US, said: “Without early treatment, up to 10 per cent of people are at risk of a major stroke in the first month after a transient ischaemic attack or acute ischaemic stroke. The THALES trial demonstrated that the risk of the composite of stroke or death at 30 days was lower with aspirin-ticagrelor than with aspirin alone.”

MND

£1m dedicated to MND research through 7 in 7 Challenge

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A £1million fund has been created to lead new research into potential treatments for Motor Neurone Disease (MND) through the efforts of an iconic challenge by Kevin Sinfeld. 

Kevin, director of rugby at Leeds Rhinos, raised over £2million through his 7 in 7 Challenge, inspired by his former team-mate and close friend Rob Burrow. 

Rhinos legend Rob was diagnosed with MND in December 2019, and Kevin completed seven marathons in as many days to help boost badly-needed research into the condition. 

Now, with £500,000 of the money raised through the 7 in 7 Challenge ring fenced for research, that sum has been matched by medical research charity LifeArc. 

The move has created a £1million joint fund established by the MND Association and LifeArc, which will support research projects focused on developing new therapies or repurposing drugs already approved for use for other conditions.

“This is fantastic news and an amazing contribution from LifeArc,” says Kevin. 

“When we set out to complete the 7 in 7 Challenge we hoped to raise awareness and funds to support the MND community but it is so wonderful to see the inspiration it has given people and organisations, like LifeArc, so they too can support the need for more research.

“Our hope, like that of everyone affected by this brutal disease including Rob, is that this money will make a real difference and help find the breakthrough we all desperately want.”

Researchers are now able to apply for a share of the funding, with the criteria that they will be expected to conclude their project within three years and be target driving with set milestones and a credible delivery plan – including a clear route to reach MND patients.

Dr Brian Dickie, director of research development at the MND Association says: “We are so grateful to LifeArc for this generous contribution and are looking forward to working with them to identify projects which have a real chance of making a difference to our community in the coming years.”

Melanie Lee, LifeArc’s chief executive, emphasised that the focus of the new funding is on boosting research around potential treatment options based on the latest understanding of the disease.

“The ambition around stimulating the search for new treatments fits with LifeArc’s approach over the last 25 years to translate early science into health care treatments or diagnostics that can transform patients’ lives,” she says. 

“Our partnership with the MND Association is the latest in a series of strategic partnerships that maximise LifeArc’s expertise in translating strong discoveries from the lab into benefitting patients with conditions with few or no effective treatment options.”

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What causes a stroke?

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Ischemic and hemorrhagic are the two main types of stroke

Over 100,000 people in the UK suffer a stroke each year, with there currently being around 1.2 million survivors living in the country.

Many people note that despite how common strokes are they remain unaware of what the actual causes of a stroke are.

Depending on which of the two types develops, causes and outcomes can differ.

What both have in common is they restrict blood flow to the brain. This leads to a reduction in the brain’s oxygen levels, which can cause tissue damage.

Here, NR Times breaks down why a stroke may occur and what risk factors there are behind each different type.

What are the different types of stroke?

There are two main types of strokes: ischaemic and hemorrhagic.

Ischemic strokes make up nearly 90 percent of all cases and they materialise when an artery which provides blood and oxygen to the brain becomes blocked. 

A hemorrhagic stroke is much less common, but happens when an artery leading to the brain bursts and starts to leak blood around or in the brain.

Causes of an ischaemic stroke

The brain is only able to function properly when its arteries supply it with oxygen-rich blood, meaning any blockages can cause lasting damage.

With a lack of blood flow, the brain is unable to make enough energy to work. If this consists for more than a few minutes, brain cells will begin to die.

This is exactly what happens in an ischaemic stroke, but there are a range of reasons as to why these blockages develop.

One of the main causes is when the arteries around the head narrow, which makes it harder for the blood to pass through.

This can also lead to something called atherosclerosis, which is where substances in the blood (such as fat or cholesterol) stick to the sides of the arteries.

Blood can build up on these deposits, causing a further increase in pressure and a reduction to the brain’s oxygen supply.

There are a number of reasons for these blockages, with the most common ones being around a person’s lifestyle.

For example, smoking can increase the risk of a stroke by up to 50 percent.

This is because nicotine not only narrows the arteries, but it also makes the heart beat faster, causing an increase in blood pressure.

Excessive alcohol intake, obesity and high cholesterol levels are also all listed as major risk factors when it comes to ischaemic strokes.

Problems with the arteries around the heart can also lead to an ischaemic stroke.

Irregular heartbeats, heart attacks and other irregularities around this area can again limit the blood’s oxygen levels.

Causes of a hemorrhagic stroke

Hemorrhagic strokes are most common in people ages 45 to 70, but they affect a lot more younger people than an ischaemic stroke.

These are caused after the arteries around the brain burst and cause bleeding.

Depending on where the artery is can affect the outcome of the hemorrhagic stroke.

If the bleeding occurs within the brain, blood shooting out at high pressure can kill some cells.

Bleeding on the surface increases the pressure in the protective layer between the brain and the skull, potentially causing more cell loss.

This bleeding is normally caused by chronically high blood pressure. In many cases, the increased pressure can cause the arteries to expand and weaken, meaning a split in them is more likely to take place.

A rarer cause of hemorrhagic stroke is where the blood vessels around the brain are connected abnormally, causing further stress on the brain. These are congenital (present at birth) but the reason for their occurrence is currently unknown.

Again, the best way to reduce the risk of an hemorrhagic stroke is to make healthy lifestyle choices.

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NHS pilots video service for epilepsy diagnoses

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A new clinical video service which supports epilepsy diagnoses and management in the era of coronavirus and beyond has been launched in the UK.

vCreate Neuro allows registered patients and carers to share smartphone-recorded videos of potential seizures or unknown movements with their clinical team via a secure, NHS-trusted system.

The data and footage act as a visual aid to assist clinical teams with rapid precision diagnostics, creating a digitised clinical pathway that minimises the need for face-to-face clinic appointments and invasive tests.

The system is currently being piloted across Scotland and, following its initial success, across England including Great Ormond Street Hospital, Evelina London and Sheffield Children’s Hospital.

The system is available to families who are concerned that they, their child or loved one may be experiencing seizures or unexplained episodes including epilepsy.

Since May 2020, more than 2,000 families have shared over 5,000 videos with their clinical teams across the platform.

Dean MacLeod was referred to the service when her seven-year-old daughter, Olivia, began having unknown movements in May 2020.

Dean uploaded videos of Olivia during these episodes as Olivia’s seizures grew more frequent.

The videos were reviewed by Paediatric Neurology professionals at the Royal Hospital for Children, Glasgow, and, supported with telephone appointments, Olivia was diagnosed with a form of epilepsy and quickly started on treatment.

Speaking about her experience, Dean said: “I’ve found vCreate to be invaluable in Olivia’s journey since she started having seizures last summer.

“We live in a remote location on the Isle of Lewis, Scotland, and we have a very limited paediatric service on the Island. The service has made it easy to access the specialist clinical knowledge needed by sending recordings of various seizure events to the Paediatric Neurology team at Glasgow.

“Since the diagnosis, I have kept in regular contact with the clinical team through the platform, sending videos and typically receiving advice from a Consultant within 24 hours which is fantastic. Between the vCreate service and telephone discussions, our family have not needed to have face-to-face consultations which has been hugely beneficial during the pandemic.”

Professor. Sameer Zuberi, consultant paediatric neurologist at the Royal Hospital for Children, Glasgow, said: “vCreate Neuro has transformed how we use carer-recorded video in our service. We are diagnosing epilepsy more rapidly, preventing misdiagnosis and saving unnecessary investigations. Families feel in more control and better connected to the service.

During the Covid-19 pandemic, many people experiencing seizures and seizure-like episodes, including children, have been unable to see a clinician.

Create Neuro aims to help by empowering patients to use asynchronous video technology for self-management, reducing the need for physical appointments. 

Founder Ben Moore said: “We’re passionate about family-forward care, and worked closely with clinical teams, patients and carers to develop the vCreate Neuro service.

“The system aims to improve patient care, reduce the number of clinic investigations – and resulting costs to the NHS – and digitise the patient pathway. We want families to be in control of their healthcare journey and have a direct link to their clinical team despite the pandemic restrictions.”

The vCreate platform has been independently assessed and approved by Information Governance teams in over 100 UK NHS Trusts.

 Within the platform, a clinical database is available as a learning resource for clinicians to study seizure types, events, and other symptoms.

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