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NCT02520921CompletedPhase 4

Aspirin Twice a Day in Patients With Diabetes and Acute Coronary Syndrome

Aspirin With a Novel Twice-a-day Administration in Diabetic Patients With Acute Coronary Syndrome to Minimize Recurrence of Acute Ischemic Events or New Urgent Revascularization

Source: ClinicalTrials.gov · Last updated 20 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
2484 (actual)
First submitted
12 Jun 2015
Start date
13 Jun 2016
Primary completion date
18 Jul 2024
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT02520921
EudraCT number
2015-000947-18

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 2484
  • From 13 Jun 2016 to the primary completion date, 18 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant anticoagulation therapy that cannot be stopped
  • Fibrinolytic therapy less than 24 hours.
  • Previous hemorrhagic stroke, previous cranial bleeding, intracranial neoplasia, arterio-venous malformation
  • Concomitant treatment with methotrexate or with chronic non-steroidal anti-inflammatory drug
  • Participant in an another investigational drug study within 30 days

Other illness

  • 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
  • Known serious hematological disorder
  • Proven gastric or duodenal ulcer in the past 3 months
  • 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

Age

  • Pregnancy or lactation or woman of childbearing age without contraception

Other

  • 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)
  • Patients under curatorship
  • No social security

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Cardiology - Lariboisiere Hospital
Coordinator of this site? Confirm its status
ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.