Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02520921
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

To compare treatment with enteric coated aspirin twice a day (100 mg in the morning and 100 mg in the evening) versus enteric coated aspirin 100 mg once per day on a composite end-point of ischemic events in diabetic patients 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Acute Coronary Syndrome Coronary Artery Disease Drug: Novel strategy Aspirin Drug: Conventional strategy Aspirin Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2574 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Arm 1 : Novel strategy
enteric coated aspirin 100 mg in the morning and 100 mg in the evening
Drug: Novel strategy Aspirin
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)

Active Comparator: Arm 2 : Conventional strategy
enteric coated aspirin 100 mg in the morning
Drug: Conventional strategy Aspirin
Aspirin once day: enteric coated aspirin 100 mg in the morning (i.e. 100mg/day)




Primary Outcome Measures :
  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 [ Time Frame: at18 months ]

Secondary Outcome Measures :
  1. Major bleeding (type 3 to 5 following BARC classification [ Time Frame: at18 months ]
  2. 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 ]
  3. Cardiac endpoint: Cardiovascular death / Myocardial infarction [ Time Frame: at18 months ]
  4. Death, myocardial infarction, stroke, urgent revascularization, stent thrombosis, acute arterial thrombotic event and major bleeding analyzed specifically and separately [ Time Frame: at18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520921


Contacts
Layout table for location contacts
Contact: Patrick HENRY, MD, PhD (33) 1 49 95 82 24 patrick.henry@lrb.aphp.fr
Contact: Jean Guillaume DILLINGER, MD (33) 1 49 95 85 74 jean-guillaume.dillinger@lrb.aphp.fr

Locations
Layout table for location information
France
Department of Cardiology - Lariboisiere Hospital Recruiting
Paris, France, 75010
Contact: Patrick HENRY, MD, PhD    (33) 1 49 95 82 24    patrick.henry@lrb.aphp.fr   
Contact: Jean Guillaume DILLINGER, MD    (33) 1 49 95 85 74    jean-guillaume.dillinger@lrb.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Bayer
Investigators
Layout table for investigator information
Principal Investigator: Patrick HENRY, MD, PhD Assistance Publique

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02520921     History of Changes
Other Study ID Numbers: P141005
2015-000947-18 ( EudraCT Number )
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diabetes mellitus
Acute coronary syndrome
Coronary artery disease
Aspirin
Secondary prevention

Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Ischemia
Syndrome
Diabetes Mellitus
Coronary Artery Disease
Coronary Disease
Acute Coronary Syndrome
Disease
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors