Diabetes MellitusPhase 4ANDAMANNCT02520921
Aspirin Twice a Day in Patients With Diabetes and Acute Coronary Syndrome
A Phase 4 study testing Novel strategy Aspirin and Conventional strategy Aspirin in people with Diabetes Mellitus and Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- Novel strategy Aspirin and Conventional strategy Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,484 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2016to 18 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Patients who show high persistent platelet reactivity under aspirin are increasingly becoming an issue of clinical concern. Several studies have suggested that giving aspirin more frequently is very effective for reducing aspirin high persistent platelet reactivity, especially in diabetic patientsor in patients with a known risk factor. The aim of the study is to evaluate low dose of aspirin twice a day (compared to once a day) for the reduction of ischemic events in diabetic patients or in patients with a known risk factor, with acute coronary syndrome.
Experimental Design:
A multicenter, randomised, parallel group comparing aspirin given twice a day compared to once per day 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.
Primary objective:
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.
Secondary objectives:
- 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 net clinical benefit combining the ischemic and bleeding 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.
- 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 cardiac 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.
- 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 in each of individual component of the main criterion.
- To confirm the safety of the innovative strategy (aspirin twice a day) concerning major bleeding events.
Study enrollment:
Multicentric national study involving 42 centers in France The duration is expected to be 24 months of recruitment. Patients will be randomized during the index hospitalization for acute coronary syndrome and before discharge between a conventional strategy of enteric coated aspirin 100mg per day with the standard of care or a innovative strategy of enteric coated aspirin 100mg morning and evening. Patients will be followed at one month, six months, one year and 18 months
Statistical analysis:
The study will include 2574 patients. We hypothesized that at 18 months, there will be an event rate of 22% for "death, MI, stroke, urgent revascularization, or acute arterial thrombotic event in the group treated with aspirin and we expect a decrease of the primary event of 20% (relative variation) using aspirin twice a day corresponding to an event rate of 17.6%.
A sample size of 1287 patients /group will allow an 80% power to detect this difference using a log-rank test at a two-sided 5% significance level. The study will include 2574 diabetic patients, or patients with a known risk factor for non-optimal aspirin response.
The primary analysis is based on the Intention To Treat population and the primary endpoint. The primary analysis on the primary endpoint will be carried out using a log-rank test for survival analysis. The 95% confidence interval of the hazard ratio will be presented. In addition the survival status during 18 months follow-up will be described by showing Kaplan-Meier curves.
Primary outcome according to pre-specified subgroups:
- Age: patients < 75 years or patient ≥75 years
- Gender: male or female
- Insulin vs no insulin treatment
- Type of acute coronary syndrome : STEMI vs NSTEMI
- Type of ADP inhibitor cotreatment
- Treatment strategy medical vs invasive (angioplasty or CABG surgery)
- Peripheral artery disease Yes/No
- GRACE score > or ≤140
- Left ventricular ejection fraction > or ≤ 40%
- Prior stroke Yes/No
- previous treatment with aspirin Yes/No
- initial HbA1C level > or ≤8%
- duration of diabetes > or ≤10 years
- Weight <60; 60-90; >90kg
- PPI use Yes/No
- Being tested
- Novel strategy Aspirin, Conventional strategy Aspirin
- Keywords
- Diabetes mellitus, Acute coronary syndrome, Coronary artery disease, Aspirin, Secondary prevention, Obesity
- Medical subject headings
- Diabetes Mellitus, Acute Coronary Syndrome, Coronary Artery Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel strategy AspirinDrug
Aspirin twice a day : enteric coated enteric coated aspirin given twice a day, 100 mg in the morning and 100 mg in the evening (i.e. 200mg/day)
Conventional strategy AspirinDrug
Aspirin once day: enteric coated aspirin 100 mg in the morning (i.e. 100mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 : Novel strategy | Active comparator | enteric coated aspirin 100 mg in the morning and 100 mg in the evening Receives: Drug: Novel strategy Aspirin |
| Arm 2 : Conventional strategy | Active comparator | enteric coated aspirin 100 mg in the morning Receives: Drug: Conventional strategy Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at18 months
Secondary outcomes (4)
Major bleeding (type 3 to 5 following BARC classification
Measured: at18 months
Net clinical benefit: Death (any), Myocardial infarction, Stroke, Urgent coronary revascularization and/or stent thrombosis, Acute arterial thrombotic event, Major bleeding
Measured: at18 months
Cardiac endpoint: Cardiovascular death / Myocardial infarction
Measured: at18 months
Death, myocardial infarction, stroke, urgent revascularization, stent thrombosis, acute arterial thrombotic event and major bleeding analyzed specifically and separately
Measured: at18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start13 Jun 2016
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Patrick HENRY, MD, PhD, Principal investigator, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520921
- Sponsor's protocol ID
- P141005
- Other IDs
- 2015-000947-18, 2015
- Acronym
- ANDAMAN
- Status last verified
- Nov 2025
- First submitted
- 12 Jun 2015
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dillinger JG, Pezel T, Batias L, Angoulvant D, Goralski M, Ferrari E, Cayla G, Silvain J, Gilard M, Lemesle G, Souteyrand G, Lim P, Roubille F, Georges JL, Bal Dit Sollier C, Petroni T, Morel O, Delarche N, Elbaz M, Puymirat E, Toupin S, Montalescot G, Drouet L, Vicaut E, Henry P; ANDAMAN Investigators of the ACTION Study Group. Aspirin dosing after acute coronary syndrome with suspected aspirin resistance: the ANDAMAN trial. Eur Heart J. 2026 Feb 11;47(6):719-730. doi: 10.1093/eurheartj/ehaf680.
PubMed 40884757Dillinger JG, Pezel T, Batias L, Angoulvant D, Goralski M, Ferrari E, Cayla G, Silvain J, Gilard M, Lemesle G, Souteyrand G, Lim P, Roubille F, Georges JL, Bal Dit Sollier C, Petroni T, Morel O, Delarche N, Elbaz M, Puymirat E, Toupin S, Montalescot G, Drouet L, Vicaut E, Henry P; ANDAMAN Investigators of the ACTION Study Group. Twice-a-day administration of aspirin in patients with diabetes mellitus or aspirin resistance after acute coronary syndrome: Rationale and design of the randomized ANDAMAN trial. Am Heart J. 2025 Oct;288:101-110. doi: 10.1016/j.ahj.2025.04.016. Epub 2025 Apr 21.
PubMed 40268181
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02520921
- Acronym / sponsor ID
- ANDAMAN / P141005
- Keywords
- Diabetes mellitus, Acute coronary syndrome, Coronary artery disease, Aspirin, Secondary prevention, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,484 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who show high persistent platelet reactivity under aspirin are increasingly becoming an issue of clinical concern. Several studies have suggested that giving aspirin more frequently is very effective for reducing aspirin high persistent platelet reactivity, especially in diabetic patientsor in patients with a known risk factor. The aim of the study is to evaluate low dose of aspirin twice a day (compared to once a day) for the reduction of ischemic events in diabetic patients or in patients with a known risk factor, with acute coronary syndrome.
Experimental Design:
A multicenter, randomised, parallel group comparing aspirin given twice a day compared to once per day 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.
Primary objective:
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.
Secondary objectives:
- 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 net clinical benefit combining the ischemic and bleeding 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.
- 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 cardiac 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.
- 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 in each of individual component of the main criterion.
- To confirm the safety of the innovative strategy (aspirin twice a day) concerning major bleeding events.
Study enrollment:
Multicentric national study involving 42 centers in France The duration is expected to be 24 months of recruitment. Patients will be randomized during the index hospitalization for acute coronary syndrome and before discharge between a conventional strategy of enteric coated aspirin 100mg per day with the standard of care or a innovative strategy of enteric coated aspirin 100mg morning and evening. Patients will be followed at one month, six months, one year and 18 months
Statistical analysis:
The study will include 2574 patients. We hypothesized that at 18 months, there will be an event rate of 22% for "death, MI, stroke, urgent revascularization, or acute arterial thrombotic event in the group treated with aspirin and we expect a decrease of the primary event of 20% (relative variation) using aspirin twice a day corresponding to an event rate of 17.6%.
A sample size of 1287 patients /group will allow an 80% power to detect this difference using a log-rank test at a two-sided 5% significance level. The study will include 2574 diabetic patients, or patients with a known risk factor for non-optimal aspirin response.
The primary analysis is based on the Intention To Treat population and the primary endpoint. The primary analysis on the primary endpoint will be carried out using a log-rank test for survival analysis. The 95% confidence interval of the hazard ratio will be presented. In addition the survival status during 18 months follow-up will be described by showing Kaplan-Meier curves.
Primary outcome according to pre-specified subgroups:
- Age: patients < 75 years or patient ≥75 years
- Gender: male or female
- Insulin vs no insulin treatment
- Type of acute coronary syndrome : STEMI vs NSTEMI
- Type of ADP inhibitor cotreatment
- Treatment strategy medical vs invasive (angioplasty or CABG surgery)
- Peripheral artery disease Yes/No
- GRACE score > or ≤140
- Left ventricular ejection fraction > or ≤ 40%
- Prior stroke Yes/No
- previous treatment with aspirin Yes/No
- initial HbA1C level > or ≤8%
- duration of diabetes > or ≤10 years
- Weight <60; 60-90; >90kg
- PPI use Yes/No
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : Novel strategy | Active comparator | Drug: Novel strategy Aspirinenteric coated aspirin 100 mg in the morning and 100 mg in the evening |
| Arm 2 : Conventional strategy | Active comparator | Drug: Conventional strategy Aspirinenteric coated aspirin 100 mg in the morning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Diabetes mellitus defined as (≥ 1 item)
- Factor of aspirin lack of efficacy defined as (≥ 1 item)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel strategy AspirinAspirin twice a day : enteric coated enteric coated aspirin given twice a day, 100 mg in the morning and 100 mg in the evening (i.e. 200mg/day) | Drug | Arm 1 : Novel strategy |
| Conventional strategy AspirinAspirin once day: enteric coated aspirin 100 mg in the morning (i.e. 100mg/day) | Drug | Arm 2 : Conventional strategy |
Primary outcome
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
Time frame: at18 months
4 secondary outcomes
Major bleeding (type 3 to 5 following BARC classification
Time frame: at18 months
Net clinical benefit: Death (any), Myocardial infarction, Stroke, Urgent coronary revascularization and/or stent thrombosis, Acute arterial thrombotic event, Major bleeding
Time frame: at18 months
Cardiac endpoint: Cardiovascular death / Myocardial infarction
Time frame: at18 months
Death, myocardial infarction, stroke, urgent revascularization, stent thrombosis, acute arterial thrombotic event and major bleeding analyzed specifically and separately
Time frame: at18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 40884757Dillinger JG, Pezel T, Batias L, Angoulvant D, Goralski M, Ferrari E, Cayla G, Silvain J, Gilard M, Lemesle G, Souteyrand G, Lim P, Roubille F, Georges JL, Bal Dit Sollier C, Petroni T, Morel O, Delarche N, Elbaz M, Puymirat E, Toupin S, Montalescot G, Drouet L, Vicaut E, Henry P; ANDAMAN Investigators of the ACTION Study Group. Aspirin dosing after acute coronary syndrome with suspected aspirin resistance: the ANDAMAN trial. Eur Heart J. 2026 Feb 11;47(6):719-730. doi: 10.1093/eurheartj/ehaf680.
- Derived from this study: PubMed 40268181Dillinger JG, Pezel T, Batias L, Angoulvant D, Goralski M, Ferrari E, Cayla G, Silvain J, Gilard M, Lemesle G, Souteyrand G, Lim P, Roubille F, Georges JL, Bal Dit Sollier C, Petroni T, Morel O, Delarche N, Elbaz M, Puymirat E, Toupin S, Montalescot G, Drouet L, Vicaut E, Henry P; ANDAMAN Investigators of the ACTION Study Group. Twice-a-day administration of aspirin in patients with diabetes mellitus or aspirin resistance after acute coronary syndrome: Rationale and design of the randomized ANDAMAN trial. Am Heart J. 2025 Oct;288:101-110. doi: 10.1016/j.ahj.2025.04.016. Epub 2025 Apr 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick HENRY, MD, PhD principal investigator
Assistance Publique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Novel strategy Aspirin and Conventional strategy Aspirin in people with Diabetes Mellitus and Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: at18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02520921, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.