A Study of Cardiovascular Events iN Diabetes Plus (NCT05441267) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study of Cardiovascular Events iN Diabetes Plus
United Kingdom21,296 participantsStarted 2023-03-13
Plain-language summary
ASCEND PLUS is testing whether, for people with type 2 diabetes who have not previously had a heart attack or stroke, regularly taking a tablet called semaglutide can safely help to reduce heart attacks, strokes, mini-strokes, the need for any procedures to unblock or bypass an artery to their heart, and the chance of dying because of vascular problems.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged at least 55 years at the time of the Screening assessment
* Type 2 Diabetes Mellitus (based on self-reported medical history)
Exclusion criteria:
* Myocardial Infarction
* Stroke
* Current or planned treatment with a GLP-1 RA
* Previous hypersensitivity to or intolerance of GLP-1 RA therapy
* Severe hypoglycaemia within the last six months or during run-in
* Symptomatic hypoglycaemia within the last month
* Currently under consideration to commence insulin
* Severe heart failure (NYHA class 4)
* Current or planned renal replacement therapy
* Unwilling to complete regular follow-up assessments
* Ongoing treatment for cancer or diagnosis with cancer (excluding non-melanoma skin cancer) in the last 2 years
* Type 1 or other type of diabetes (e.g. MODY)
* History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
* Currently breastfeeding or pregnant, or planning a pregnancy
* Any serious illness which is likely to limit survival or active participation for at least 5 years
* Current participation in a clinical trial with an unlicensed investigational medicinal product used to treat diabetes
* For participants taking thyroxine, lack of agreement to arrange a thyroid function test in the next 3 months and agree to regular testing throughout the trial
* Non-adherence to run-in treatment (i.e. reports taking the run-in tablets 'Never' or 'Only occasionally')
* Their doctor does not wish them to be randomised
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to the first occurrence of a Major Adverse Cardiovascular Events (MACE+)
Timeframe: Scheduled treatment period (anticipated median follow-up period of 5-years)