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NCT06716255Completed

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

Observational Single-center Comparative Study of the Efficacy of Buffered Acetylsalicylic Acid and Enteric-coated Acetylsalicylic Acid on Platelet Aggregation in Patients With Chronic Coronary Syndrome and Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov · Last updated 4 Dec 2024

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Observational
Enrollment
200 (actual)
First submitted
29 Nov 2024
Start date
29 Feb 2024
Primary completion date
17 May 2024
Lead sponsor
Nizhpharm
NCT number
NCT06716255

What you commit to

  • Study type: Observational
  • Participants enrolled: 200
  • From 29 Feb 2024 to the primary completion date, 17 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with bronchial asthma induced by taking salicylates and non-steroidal anti-inflammatory drugs;
  • Patients with future planned coronary bypass surgery, percutaneous coronary intervention or any other revascularisation in which dual antiplatelet therapy should be administered;

Other illness

  • 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 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 ongoing haemorrhage;
  • Patients with active psychiatric, infectious diseases and cancer;
  • Patients with chronic heart failure of New York Heart Association (NYHA) functional class III-IV (FC);

Lab values

  • Patients with severe renal disease (serum creatinine\>2.5 mg/dL \[221 micromol/L\]) or estimated creatinine clearance \<30 mL/min;
  • Patients with congenital lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

Other

  • Patients with erosive-ulcerous lesions of the gastrointestinal tract (in the exacerbation phase);
  • Pregnant, lactating women;
  • Patients with known coagulopathies, thrombocytopathies, thrombocytopenia;
  • Patients taking methotrexate (more than 15 mg per week).

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba)
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.