THE USE OF ASPIRIN AS PRIMARY PREVENTION IN PATIENTS WITH DIABETES

THE USE OF ASPIRIN AS PRIMARY PREVENTION IN PATIENTS WITH DIABETES - ASPIRIN PROTOCOL

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003064-21-ES

Enrollment

180

Registered

2014-09-22

Start date

2015-01-15

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular prevention in patients diagnosed in diabetes mellitus MedDRA version: 20.0 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ Class: 100000004860

Interventions

Trade Name: ACYD ACETIL SALYCILIC Product Name: acyd acetil salycilic Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: ASPIRINE Other descriptive name: ACETYLSALICYLIC ACID Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria CASES: 1. Patients of both sexes aged between 18 and 40. 2. Outpatients visited regularly in our outpatient center or reference area of the Diabetes Unit of Endocrinology and Nutrition Territorial Girona (UDENTG) diagnosed with type 1/2 diabetes for at least 1 year of evolution. 3.patients with diabetes mellitus (as type 1 and type 2) who meet the criteria for metabolic syndrome defined as: - Central obesity (BMI> 30kg/m2) HIGH-LIMIT or => 94 cm and women> or => 80 cm - More than two of any of the following factors: o Increased triglycerides:> 150 mg / dl or specific treatment for this lipid abnormality. or decrease in HDL-C 130 mmHg or diastolic> 85 mm Hg or specific treatment of previously diagnosed hypertension. o Increased blood glucose: ? fasting blood glucose> 100 mg / dl or ? previously diagnosed type 2 diabetes. 4. Affects type 1/2 patients who met diagnostic criteria for NO metabolic syndrome (as defined in paragraph 3) diabetes. 5. Signed informed consent priot to participation in the study. - Inclusion criteria CONTROLS: 1. Patients of both sexes aged between 18 and 40. 2. Outpatients visited regularly in our outpatient center or reference area of the Diabetes Unit of Endocrinology and Nutrition Territorial Girona (UDENTG) fulfilling diagnostic criteria for metabolic syndrome that are NOT diabetic. 3. Volunteers Healthy individuals without a diagnosis of diabetes or who meet diagnostic criteria for metabolic syndrome. 4. Signed informed consent prior to participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. History of previous cardiovascular disease, uncontrolled hypertension, ischemic or hemorrhagic gastrointestinal disease and asthma stroke. 2. Severe systemic disease unrelated to diabetes and cancer, severe liver or renal disease. 3. Previous use of chronic treatment with aspirin or any other antiplatelet drug (in the two weeks prior to baseline). 4. Hematologic or coagulation Pathology. 5. Hypersensitivity to aspirin. 6. Treatment that could interact with AAS as acetazolamide, anticoagulants, antineoplastic agents, alcohol, antacids, corticosteroids, other NSAIDs, methotrexate, niacin, anticonvulsants, and antidepressants alendròmic acid. 7. Recent vaccination (less than 2 months). 8. Pregnancy and lactation. 9. Persons released on legal or administrative requirement. 10. Symptoms and clinical signs of infection in the month prior to recruitment. 11. History of major psychiatric at the discretion of the investigator

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The primary endpoint of our study is the degree of antiplatelet therapy in different population groups.;Timepoint(s) of evaluation of this end point: at day 0 and 7;Main Objective: Compare platelet reactivity in different subgroups of diabetic population without prior vascular disease (such as diabetes 1 and type 2 diabetics) with and without metabolic syndrome criteria on what happens in the general healthy population.;Secondary Objective: 1. Define the phenotypic characteristics of individuals according to their platelet reactivity 2.Compare the effectiveness of different treatment regimens with aspirin in these subgroups of patients versus the general healthy population. 3. Assess endothelial dysfunction 4. Assess the status/level of inflammation	—

Measure

Time frame

Primary end point(s): The primary endpoint of our study is the degree of antiplatelet therapy in different population groups.;Timepoint(s) of evaluation of this end point: at day 0 and 7;Main Objective: Compare platelet reactivity in different subgroups of diabetic population without prior vascular disease (such as diabetes 1 and type 2 diabetics) with and without metabolic syndrome criteria on what happens in the general healthy population.;Secondary Objective: 1. Define the phenotypic characteristics of individuals according to their platelet reactivity 2.Compare the effectiveness of different treatment regimens with aspirin in these subgroups of patients versus the general healthy population. 3. Assess endothelial dysfunction 4. Assess the status/level of inflammation

—

Secondary

Measure	Time frame
Secondary end point(s): Demographyc and clinical data Medical history cormobidities Concomitant medication Complete physical examination Blood sample;Timepoint(s) of evaluation of this end point: Last day of study	—

Countries

Spain

Contacts

Public ContactCristina Martinez

Hospital Universitari de Girona Dr. Josep Trueta

cmartinez@idibgi.org00349729402002343

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026