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

NCT02520921 | Completed Phase 4

• 2 other identifiers: P1410052015-000947-18
• Study Type: interventional
• Target: 2,484
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Acute Coronary Syndrome; Coronary Artery Disease; Obesity

Keywords

Diabetes mellitus; Acute coronary syndrome; Coronary artery disease; Aspirin; Secondary prevention; Obesity

Outcome Measures

Primary Outcomes (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

  at18 months

Secondary Outcomes (4)

• Major bleeding (type 3 to 5 following BARC classification

  at18 months

• Net clinical benefit: Death (any), Myocardial infarction, Stroke, Urgent coronary revascularization and/or stent thrombosis, Acute arterial thrombotic event, Major bleeding

  at18 months

• Cardiac endpoint: Cardiovascular death / Myocardial infarction

  at18 months

• Death, myocardial infarction, stroke, urgent revascularization, stent thrombosis, acute arterial thrombotic event and major bleeding analyzed specifically and separately

  at18 months

Study Arms (2)

Arm 1 : Novel strategy

ACTIVE COMPARATOR

enteric coated aspirin 100 mg in the morning and 100 mg in the evening

Drug: Novel strategy Aspirin

Arm 2 : Conventional strategy

ACTIVE COMPARATOR

enteric coated aspirin 100 mg in the morning

Drug: Conventional strategy Aspirin

Interventions

Novel strategy Aspirin DRUG

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)

Arm 1 : Novel strategy

Conventional strategy Aspirin DRUG

Aspirin once day: enteric coated aspirin 100 mg in the morning (i.e. 100mg/day)

Arm 2 : Conventional strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus defined as (≥ 1 item)
• Treated diabetes mellitus
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Bayer: collaborator

Study Sites (1)

Department of Cardiology - Lariboisiere Hospital

Paris, 75010, France

Location

Related Publications (2)

• 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. 2025 Aug 30:ehaf680. doi: 10.1093/eurheartj/ehaf680. Online ahead of print.

  PMID: 40884757 DERIVED

• 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. 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.

  PMID: 40268181 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Acute Coronary Syndrome; Coronary Artery Disease; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick HENRY, MD, PhD

  Assistance Publique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: August 13, 2015
• Study Start: June 13, 2016
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

FR (1)