Imagine taking a medication every day that’s supposed to protect you from a heart attack—only to learn years later that it might not work as well as you were told.
That’s the unsettling reality now facing millions of patients who’ve been prescribed a well-known anti-clotting drug called ticagrelor, sold under the brand name Brilinta.
This medication, approved for NHS use back in 2011, is meant to reduce the risk of death or further heart complications in people recovering from a heart attack or dealing with severe chest pain.
But new concerns suggest its effectiveness might have been overstated—possibly even misrepresented during the approval process.
What Is Ticagrelor and Why Was It So Widely Prescribed?
Ticagrelor is often given to patients with acute coronary syndrome, a term that includes conditions like heart attacks and unstable angina.
It works by stopping platelets in the blood from clumping together and forming dangerous clots.
At the time of its launch, clinical trial results made headlines for claiming the drug could prevent 1 in 5 deaths after a heart attack.
That led to widespread use in the UK and US, with NHS doctors prescribing it roughly 45,000 times a month.
Serious Questions Raised About the Drug’s Trials
Now, a new BMJ investigation is raising red flags.
According to the report, there were major inconsistencies in two of the key clinical trials used to approve ticagrelor in both the UK and US.
Researchers say there’s “evidence of serious misreporting” in the data submitted for regulatory review.
In particular, the journal Circulation—which published the results—allegedly omitted a quarter of the readings from platelet testing machines.
Those missing results could have revealed higher-than-expected clotting activity, which the drug was supposed to prevent.
A Decade-Long Critic Speaks Out
Dr. Victor Serebruany, a cardiovascular pharmacology expert from Johns Hopkins University, has been sounding the alarm on ticagrelor for years.
Now, with BMJ’s findings in hand, he’s doubling down.
“It’s been obvious for years something wasn’t right,” he said.
“If doctors had seen the real data, they never would’ve prescribed it.”
He also criticized US regulators, especially the FDA, for allegedly ignoring warning signs during their own review process.
What Was Found in the Trials?
Digging into the phase 2 trials, investigators noted some patients actually experienced a rise in blood clotting activity—a direct contradiction to what ticagrelor is meant to do.
The trials were led by Dr. Paul Gurbel, whose team at the Sinai Center for Thrombosis Research is now under scrutiny.
Out of 282 platelet readings, more than 60 were reportedly excluded from the final analysis given to the FDA.
Strangely, those left-out readings showed significantly higher platelet activity—meaning the drug wasn’t stopping the clots as promised.
A spokesperson for Dr. Gurbel’s research center dismissed the allegations as “baseless and erroneous.”
What This Means for Patients in the UK
Ticagrelor isn’t just for heart attack recovery—it’s also given to patients after minor strokes or transient ischaemic attacks (mini-strokes), usually alongside aspirin.
In the UK, the NICE guidelines recommend the drug at 90mg twice daily for a year after a heart attack, sometimes followed by a lower 60mg dose for up to three more years.
That’s a long time to stay on a drug that might not be performing as promised.
And with the BMJ’s findings now public, both doctors and patients are being urged to take a closer look at the benefits versus risks.
AstraZeneca Responds to the Controversy
Pharmaceutical giant AstraZeneca, which manufactures Brilinta, defended the drug in a statement to MailOnline, saying:
“We are confident in the integrity of the trials and the evidence supporting Brilinta’s use.”
Still, the journal Circulation, which published the original studies, did not respond to requests for comment from the BMJ.
The Bigger Picture: How Blood Clots Threaten the Heart
To understand why this is so serious, it’s important to know how blood clots affect heart health.
After a heart attack—or as we age—our bodies may start to overproduce clots, which can block arteries and lead to more heart attacks, strokes, or even aneurysms.
Drugs like ticagrelor are designed to reduce this risk by stopping platelets from clumping.
But if that mechanism isn’t working as intended, patients may be left vulnerable.
What Happens Next?
With the BMJ’s investigation casting a shadow over ticagrelor’s early trials, there are calls for regulatory reviews, more independent studies, and perhaps even changes in prescribing practices.
For patients currently on the drug, experts aren’t recommending an immediate stop—but they do suggest speaking with your doctor about whether it’s still the right treatment for your condition.