I felt confused and surprised as the two other medics approached me.
It was December 2020 and the previous day I’d spent more than ten hours in A&E in a blur of tests, examinations and pill-popping after a suspected stroke.
I’d been speaking to a friend on the phone when, without warning, I felt extreme dizziness and mounting nausea. Then I couldn’t control my right hand any more, my right leg was wobbly and I was overwhelmed by fatigue.
I was admitted in the early hours, and that day was filled with scans and tests, with me still in disbelief that I’d gone from apparent good health to having a stroke.
It was December 2020 and the previous day I’d spent more than ten hours in A&E in a blur of tests, examinations and pill-popping after a suspected stroke
Two men who claimed to be hospital researchers approached me with a request for help. They wanted to enrol me on a clinical trial studying the effect of a new anticoagulant, a drug to prevent blood clots, the cause of the most common type of stroke — an ischaemic attack, which I’d had.
This is when a blood vessel supplying the brain becomes blocked — brain cells and tissue can start to die off within minutes, which explains the sudden onset of catastrophic symptoms.
Anticoagulants reduce fibrin formation, which is a protein that would otherwise create a fibrous mesh on a cut to restrict blood flow.
It was explained that I’d be taking two pills daily for a year, and I had a 25 per cent chance of it being a placebo or the drug (known as Bay 2433334) in one of three doses — 10 mg, 20 mg or 50 mg.
Because the trial was ‘double blind’ neither researcher nor participant knew who got what.
The trial required five hospital visits (Charing Cross in London, Imperial Healthcare Trust), for various testing. In the remaining seven months, a researcher would call to monitor my health.
I was able to have as many as four ECGs and up to three MRIs throughout the year to assess my heart function. The 15-page info sheet gave me the information that there would be approximately 1,900 participants across 24 countries.
Because the trial was ‘double blind’ neither researcher nor participant knew who got what. The stock image above is taken from a photo that was available online.
While the data did not guarantee any benefits, the researchers suggested that the participants might be more likely to benefit from the additional health screenings.
Of course, as a health journalist I couldn’t help but think of the catastrophic Elephant Man drugs trial of 2006, which left six fit young men in intensive care. It was conducted in a London private hospital wing. The drug used in the trial to treat leukaemia, chronic inflammation, and other conditions.
The drug worked by manipulating the immune system, and it sent the young men’s systems into overdrive. Five men spent three weeks in hospital. Sixteen, with a large swelling of the face, were there for four more months.
The dizziness I’d experienced at the start of the stroke had largely gone and my thinking was beginning to feel clearer. Although I was still stunned at the outcome, I was surprised at how rationally and objectively I weighed the possibility of participating in the trial.
I was able ask questions and discovered that there had been an increase in safety measures after the Elephant Man accident.
According to me, the drug that I was asked to try had been tested in human trials in smaller scales. I figured this meant that there was less risk.
Unfortunately, doctors aren’t able to say what caused my stroke, although my blood pressure was very high on admission.
I’d had Covid-19 badly and as the virus makes blood stickier, it could have been caused by that, but no one could confirm the link.
A frightening 30% chance of having another stroke in the first two years without any obvious cause is possible.
It was enough for me to be reintroduced to the drug trial. However, the experience gave me a new lease of life.
My stroke happened in the cerebellum. It is responsible for balance coordination and posture as well as eye movement and vision.
So in addition to balance and co-ordination problems on my right-hand side, I’d lost fine motor skills in that hand, including handwriting, something integral to my life and work. Anything that might prevent worse happening was worth it, I thought, as I signed my consent to the trial with a scrawl — all I could manage.
Looking around me on the hyper acute stroke ward, sadly I could see several patients severely affected who didn’t appear to move, talk or eat. When I was discharged a day later, I felt a real zeal about doing my little bit to help improve medication for others — also giving me a sense of purpose at a time when I couldn’t even write a Christmas card.
My functions are slowly returning, and I have been practicing writing exercises and typing for the past year. Just recently, I completed the drug trial. It is clear that regular monitoring helped me feel safe, especially when I did two ECGs in December and June. Also, an MRI was done in June as part of my trial. Both showed no silent strokes, and that my heart rate was normal.
I was petrified about the risk of a second stroke, especially as I didn’t smoke and already ate a Mediterranean diet — two of the suggested methods for avoiding further events — so all that was left to me to do was take my newly prescribed pills with alacrity.
Although not pleasant, the MRI was a great bonus and relief. I had blood pressure checks every two months (in total, five). They were all normal.
It’s not yet clear when the findings of this trial are due — and, of course, I don’t know if I was taking the trial drug or a placebo. I was the first patient recruited at Charing Cross and, being an optimist, I like to think I’d been allocated the drug and it was doing me good.
Only if there is a medical emergency, and the doctor has to know what I took, will this information be disclosed. Participating in the program was a great experience.
Patients who are unable to attend such trials can pose a problem for recruiters. One more is the fact that patients may arrive on weekends or at night to receive stroke medicine. There is also patients’ fear of the unknown at a time when they’re already dealing with a new health scare — and the ‘reputation’ of trials themselves.
Jane Armitage, a professor of clinical trials and epidemiology at Oxford University, was running a trial on statins at the time of the Northwick Park trial in 2006, which ‘impacted our ability to recruit’, she says. But she believes Covid vaccines and the work of the Recovery trial, to establish which treatments do and do not work on Covid patients, ‘has restored some of that confidence’.
Dr Dheeraj Kalladka, a consultant neurologist and stroke physician at Charing Cross Hospital, who is involved in the stroke trial, adds: ‘Clinical trials are not experiments that doctors randomly dream up, and patients should not think of themselves as guinea pigs.
‘A lot of thought goes into developing clinical trials. And the more patients get involved and see trials as positive, the more we can improve care and tailor medicines.’
Professor Armitage noted that even people who are given placebo treatments have shown better results than those who were not on trial.
‘Some of that is because health problems might be picked up earlier because the participants are being monitored.’
She adds: ‘Drugs trials are vitally important to make sure the medicines prescribed by our doctors are safe and effective. We don’t get a huge response rate, but we’d like people to consider it carefully.’
To find out more about taking part in a UK trial, check the websites of relevant medical charities, and the Be Part of Research website: bepartofresearch.nihr.ac.uk