Active not recruitingPHASE4INTERVENTIONAL

ASCEND: A Study of Cardiovascular Events iN Diabetes

The ASCEND study investigated if taking 100mg of aspirin daily, or 1 gram of omega-3 fatty acids, or both, could stop serious health issues like heart attacks and strokes in people with diabetes who hadn't experienced them previously. These serious issues also included mini-strokes or death from heart-related conditions. Researchers also looked into whether these treatments caused any serious side effects, such as major bleeding. The study found that aspirin did reduce the risk of heart attacks and strokes, but it also increased the risk of major bleeding. Omega-3 fatty acids were not found to have a significant effect on preventing these serious events. This study helps us understand the best ways to keep people with diabetes healthy.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

University of Oxford

Enrolment target

15,480

Start

01 Mar 2005

Estimated completion

31 Jul 2037

Diabetes Mellitus

Results

Results from this study

Posted April 2019

Results have been published for this study.

Primary outcome

Number of Participants With First Occurrence of Any Serious Vascular Event (SVE)

The primary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 fatty acids versus placebo on the first occurrence of any "Serious Vascular Event" (SVE), defined as: * non-fatal myocardial infarction; or * non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or * vascular death excluding confirmed intracranial hemorrhage (defined as International Classification of Diseases 10th revision \[ICD-10\] I00-52 or I63-99, i.e. excluding subarachnoid hemorrhage \[I60\], intracerebral hemorrhage \[I61\], and other non-traumatic intracranial hemorrhage \[I62\]).

Full results on the registry

What is this study about?

The ASCEND study, which stands for "A Study of Cardiovascular Events iN Diabetes," was a large research project that wanted to understand if certain widely available medicines could help people with diabetes avoid serious health problems. Specifically, it looked at whether a low dose of daily aspirin (100mg) or a daily omega-3 supplement (1 gram of fish oils) could prevent heart attacks, strokes, mini-strokes, or death due to heart and blood vessel conditions. Researchers also checked for any serious side effects like bleeding complications.

Doctors already know that aspirin can prevent heart attacks and strokes in people who have previously had these conditions, or who have existing blood vessel problems. However, many people with diabetes, especially those who are younger or middle-aged, haven't yet developed these problems but are still at higher risk. There wasn't much clear research about whether aspirin would help these specific individuals. Similarly, some studies suggested that fish oils might be good for heart health, but more proof was needed for people with diabetes.

The initial findings of the ASCEND study, published in 2018, showed some important results. They found that taking a daily aspirin did help to prevent serious heart and blood vessel problems in people with diabetes who hadn’t had them before. However, this benefit came with a downside: taking aspirin also led to a similar increase in major bleeding episodes, and it didn't affect cancer risk. The study also concluded that omega-3 supplements did not make a significant difference in preventing these serious events. Researchers are continuing to follow up with participants for 20 years to see the long-term effects.

Key takeaways

Aspirin helped prevent heart attacks and strokes in people with diabetes who hadn't had them before.
Aspirin increased the risk of major bleeding.
Omega-3 fatty acids (fish oils) did not prevent heart attacks or strokes in this group.
The study highlights the balance between benefits and risks of common medicines.
Long-term follow-up is continuing for 20 years to understand lasting effects.

Who may be eligible?

Generally, to have been part of this study, you would have needed to be at least 40 years old and have either type 1 or type 2 diabetes. A key requirement was that you should not have had any previous heart attacks, strokes, or other known serious blood vessel problems. It was also important that you didn't have any major health issues that would put your life at risk for other reasons.

There were also reasons why someone couldn't join. For example, if you had already suffered a heart attack or stroke, or had operations to improve blood flow in your arteries, you wouldn't have been eligible. Also,, if you were already taking aspirin regularly, warfarin, or any other type of medicine that thins the blood, you could not participate in this study. Lastly, you couldn't have any clear reasons, as decided by a doctor, why you shouldn't take aspirin.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 40 years old or older?
Do you have type 1 or type 2 diabetes?
Have you *never* had a heart attack, stroke, or other serious blood vessel problems?
Are you *not* currently taking aspirin, warfarin, or other blood-thinning medicines?
Does your doctor agree there's no reason why you shouldn't take aspirin?

Answer every question to see your result.

What does participation involve?

If you had taken part in the ASCEND study, you would have been asked to take either a daily aspirin, a daily omega-3 supplement, a placebo (a dummy pill that looks like the real thing but contains no active medicine) for aspirin, or a placebo for omega-3s. This means you wouldn't have known which treatment you were getting. You would have been regularly assessed by the study team, typically through visits or phone calls, to check on your health and any new medical events. The study involved taking the assigned medication daily over several years. After the initial period, the researchers continued to follow up with participants for 20 years beyond the main study period to understand the very long-term effects of the treatments, usually through questionnaires or checking medical records. The total duration of active treatment was several years, followed by extended observation.

Potential risks and benefits

Participating in a study like ASCEND could offer potential benefits by helping researchers understand if treatments like aspirin or omega-3s could prevent serious health problems in people with diabetes. While participants might not directly benefit, the results help doctors make better recommendations for future patients. However, there are always potential risks, such as side effects from the medicines (like increased bleeding risk with aspirin) or the inconvenience of study visits. It's crucial to remember that participation is always voluntary. You would have had the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Clinical Trial Service Unit, NDPH, University of Oxford
Verified postcode
Oxford, United Kingdom

Common questions

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers see if a medicine really works or if people just feel better because they think they're getting treatment.

Why is this study important for people with diabetes?

People with diabetes have a higher risk of heart attacks and strokes. This study helped doctors understand if simple medications like aspirin or fish oil could safely lower that risk for those who haven't had these problems before.

Did the study involve both Type 1 and Type 2 diabetes?

Yes, people with either type 1 or type 2 diabetes were able to take part in this study, provided they met the other entry requirements.

What did the study find out about omega-3s?

The study found that taking 1 gram of omega-3 fatty acids daily did not significantly reduce the risk of serious heart problems or strokes in people with diabetes.

Is the study still going on?

While the main treatment phase and initial results were published in 2018, the researchers are still following up with participants to see the effects over 20 years.