Could Twice-Daily aspirin save diabetic hearts?
NCT ID NCT02520921
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether taking aspirin twice a day (200 mg total) works better than the standard once-daily dose (100 mg) to prevent another heart attack, stroke, or urgent heart procedure in diabetic patients who recently had a heart attack. About 2,500 participants were followed for 18 months. The goal was to see if splitting the dose reduces ischemic events without causing more bleeding.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aspirin (enteric coated)
- What this could lead to
- If successful, this could show that a simple change in aspirin dosing reduces the risk of repeat heart attacks or strokes in diabetic patients.
- What could go wrong
- This is a completed Phase 4 trial, but the benefit may be small and bleeding risk could increase with higher total aspirin dose. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
2,484 people
The number who actually took part.
- Started
-
Jun 2016
- Finished
-
Jul 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 and ≥18 years old Exclusion Criteria: * Allergy or contraindication to aspirin (Hypersensitivity to aspirin or any of the excipients, history of asthma induced by the administration of salicylates, ongoing peptic ulcer, constitutional or acquired haemorrhagic disease including gastrointestinal bleeding, history of hemorrhagic stroke and thrombocytopenia, pregnancy after 24 weeks of gestation, risk of bleeding, severe renal failure, severe hepatic impairment, uncontrolled severe heart failure * Concomitant anticoagulation therapy that cannot be stopped * Fibrinolytic therapy less than 24 hours. * Unstable patients according to investigator: use of amine or mechanical device (IABP, ECMO or similar) or mechanical ventilation during index hospitalization * Index event is an acute complication of coronary revascularization (PCI or CABG) * Known serious hematological disorder * Proven gastric or duodenal ulcer in the past 3 months * Previous hemorrhagic stroke, previous cranial bleeding, intracranial neoplasia, arterio-venous malformation * Any condition that may put the patient at risk or influence study result in the investigators' opinion (active cancer ….) or that increase the risk for non-compliance or being lost to follow-up * Concomitant treatment with methotrexate or with chronic non-steroidal anti-inflammatory drug * Pregnancy or lactation or woman of childbearing age without contraception * Participant in an another investigational drug study within 30 days * Patients under curatorship * No social security
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Department of Cardiology - Lariboisiere Hospital
Paris, 75010, France
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