Aspirin Twice a Day in Patients With Diabetes and Acute Coronary Syndrome (NCT02520921) | Clinical Trial Compass
CompletedPhase 4
Aspirin Twice a Day in Patients With Diabetes and Acute Coronary Syndrome
France2,484 participantsStarted 2016-06-13
Plain-language summary
To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome. It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic event after acute coronary syndrome in diabetic patients or in patients with a known risk factor.
Who can participate
Age range
18 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:
* Diabetes mellitus defined as (≥ 1 item)
* Treated diabetes mellitus
* 2 fasting glucose levels ≥ 7 mmol/l after admission
* glucose level ≥ 11 mmol/l after admission (any moment)
* HbA1C ≥ 6.5% OR
* Factor of aspirin lack of efficacy defined as (≥ 1 item)
* Obesity defined as BMI≥27kg/m2
* Waist circumference ≥ 88cm for women or ≥102cm for men
* Index event occurring under chronic low dose of aspirin (\<300mg)
AND
\- Acute coronary syndrome defined as:
* Acute coronary syndrome with ST-segment elevation (STEMI) is defined as chest pain (≥ 30min) with persistent ST-segment elevation in at least two contiguous leads (≥1mm) or a new left bundle-branch block and the intention to perform primary PCI or thrombolysis.
* Acute coronary syndrome without ST-segment elevation (NSTEMI) is defined as universal myocardial definition:
Detection of cardiac biomarker values elevation \[preferably cardiac troponin (cTn)\] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
* Symptoms of ischemia
* New or presumed new significant ST-segment-T wave (ST-T) changes except ST elevation
* Development of pathological Q waves in the ECG
* Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
* Identification of an intracoronary thrombus by angiography
* included after the angiography showing stenosis ≥50% and before discharge
* signed informed consent a…
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
first main vascular event occurring within the 18 months after randomization among the following: Death (any), Myocardial infarction, Stroke, Urgent coronary revascularization and/or stent thrombosis, Acute arterial thrombotic event