Comparison of Effects of Buffered and Enteric-coated Forms of Aspirin on Platelet Aggregation in Patients With Diabetes Mellitus and Chronic Coronary Syndrome

NCT06716255 | Completed

• 2 other identifiers: ASA-NIS-2023NP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with diabetes mellitus are characterized by "hyperreactive" platelets and a reduced response to ASA compared to individuals without diabetes. ASA that is absorbed in the intestine is slower to enter the bloodstream and become therapeutic concentrations compared to ASA that is absorbed in the stomach. It seems rational to test the hypothesis that the use of buffered ASA may be more effective in patients with diabetes and chronic coronary syndrome (CCS).

Conditions

Diabetes Mellitus Type 2; Coronary Artery Diseases; Aspirin Resistance

Keywords

chronic coronary syndrome; diabetes mellitus; platelet aggregation; resistance to acetylsalicylic acid

Outcome Measures

Primary Outcomes (1)

• Frequency of resistance to acetylsalicylic acid by VerifyNow Aspirin test

  Frequency of development of high residual platelet reactivity while taking acetylsalicylic acid in buffered form (Cardiomagnil) compared to taking acetylsalicylic acid in an enteric-coated form (Aspirin® Cardio/Trombo Ass®) according to the VerifyNow Aspirin clinical test.

  Evaluated one time. Patient has been taking acetylsalicylic acid in one of the forms with control of compliance for 7 preceding days before the test.

Secondary Outcomes (2)

• Frequency of acetylsalicylic acid resistance according to light transmission aggregometry results

  Evaluated one time. Patient has been taking acetylsalicylic acid in one of the forms with control of compliance for 7 preceding days before the test.

• Combined clinical endpoint (any bleeding + re-hospitalisation for any cause + death)

  Identified by call 180 days after inclusion in the study

Study Arms (2)

Group 1

Patients receiving the buffered form of ASA

Group 2

Patients receiving the enteric-coated form of ASA

Eligibility Criteria

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

Study Population

200 adult patients of both sexes with an established diagnosis of CCS and DM2 who were prescribed buffered acetylsalicylic acid (Cardiomagnil) or acetylsalicylic acid in an enteric-coated form (Aspirin® Cardio or Thrombo ACC®) prior to inclusion in the study.

You may qualify if:

• Patients (men and women) aged 18 years and older with chronic coronary syndrome and DM2;
• Patient is taking Cardiomagnil (75 mg/day) - buffered form ASA or Aspirin® Cardio (100 mg/day) or Thrombo ACC® (100 mg/day) enteric-coated form ASA on a regular basis;
• Signed informed consent.

You may not qualify if:

• Patients with conditions that require anticoagulant therapy (e.g., atrial fibrillation, mechanical heart valves, etc.) or dual antiplatelet therapy (recent percutaneous coronary intervention, coronary bypass, myocardial infarction, cerebral infarction, etc.);
• Patients with severe renal disease (serum creatinine\>2.5 mg/dL \[221 micromol/L\]) or estimated creatinine clearance \<30 mL/min;
• Patients with a history of intracranial haemorrhage;
• Patients with any contraindications to acetylsalicylic acid, including known allergy or hypersensitivity to acetylsalicylic acid, drug excipients, or other nonsteroidal anti-inflammatory drugs;
• Patients with bronchial asthma induced by taking salicylates and non-steroidal anti-inflammatory drugs;
• Patients with erosive-ulcerous lesions of the gastrointestinal tract (in the exacerbation phase);
• Patients with future planned coronary bypass surgery, percutaneous coronary intervention or any other revascularisation in which dual antiplatelet therapy should be administered;
• Pregnant, lactating women;
• Patients with ongoing haemorrhage;
• Patients with known coagulopathies, thrombocytopathies, thrombocytopenia;
• Patients with active psychiatric, infectious diseases and cancer;
• Patients with chronic heart failure of New York Heart Association (NYHA) functional class III-IV (FC);
• Patients with congenital lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• Patients taking methotrexate (more than 15 mg per week).

Sponsors & Collaborators

• Nizhpharm: lead
• Federal Scientific Clinical Centre of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogache: collaborator

Study Sites (1)

University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba)

Moscow, 117292, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Imad Akhmad Merai, Head of CCU

  University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: February 29, 2024
• Primary Completion: May 17, 2024
• Study Completion: September 24, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Supporting information will be available after the publication of the article and indefinitely.
• Access Criteria: Any researcher can get access, you just need to write to the contact email address

Locations

RU (1)