Coronary Artery Disease (CAD) or Symptomatic Peripheral Artery Disease (PAD) or after Acute Coronary Syndrome (ACS) MedDRA version: 20.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders MedDRA version: 21.1 Level: LLT Classification code 10067825 Term: Peripheral arterial disease System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System
Conditions
Interventions
Trade Name: HerzASS-ratiopharm® 50 mg tablets
Product Name: HerzASS-ratiopharm® 50 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Acetylsalicylic acid
CAS Number: 50-78-2
Concentration un
Sponsors
Adamed Pharma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. diagnosis of coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) or recent occurrence of acute coronary syndrome (ACS); 2. age of =18 years old; 3. patients who were prescribed ASA EC tablets 100 mg or ASA IR tablets 100 mg or ASA EC tablets 75 mg or ASA IR tablets 75 mg and in the opinion of the Principal Investigator can be switched to ASA IR tablets 100 mg. 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 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: 1. blood disorders; 2. aspirin resistance (>550 ARU on VerifyNow® Aspirin Test); 3. patients treated with oral anticoagulants, thrombolytic agents, non-steroidal anti-inflammatory drugs in the period 2.5 times the upper limit of normal; 13. platelet count =600 × 103/ mm3 or =150 × 103/mm3; 14. hematocrit =50% or =25%; 15. low compliance before enrolment; 16. uncontrolled diabetes mellitus (stable drug doses within last 3 months before randomization); 17. end stage kidney disease with glomerular filtration rate <15 mL/min or on hemodialysis; 18. pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception e.g., intrauterine device, oral contraception or progesterone implant. Pregnancy must be excluded by a negative pregnancy test at Visit 1; 19. renal artery stenosis or kidney transplantation; 20. hypersensitivity to any component of the investigational products; 21. chronic liver disease; 22. concomitant or previous treatment with any other investigational drug within 20 days of enrolment; 23. as per the Investigator (or his designee) judgment, subject cannot participate in the study for any reason (e.g., medical, psychiatric and/or social reason).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate equivalence in inhibiting platelet aggregation and platelet thromboxane production between acetylsalicylic acid tablets 50 mg administered twice daily and acetylsalicylic acid tablets 100 mg administered once daily.;Secondary Objective: •To evaluate sTxB2 levels and platelet aggregation response in obese and non-obese patients •To evaluate pharmacodynamics of sTxB2 in patients receiving acetylsalicylic acid tablets 50 mg twice daily and acetylsalicylic acid tablets 100 mg once daily (optional for patients who sign separate Informed Consent Form for additional biological material collection) •To evaluate safety ;Primary end point(s): 1)Difference in sTxB2 levels measured with analytical ELISA methods after 10 days of twice daily ASA 50 mg tablets compared to 10 days of once daily ASA 100 mg tablets. 2)Difference in platelet reactivity measured with VerifyNow® Aspirin Test after 10 days of twice daily ASA 50 mg tablets compared to 10 days of once daily ASA 100 mg tablets . ;Timepoint(s) of evaluation of this end point: Participants receive treatment and are monitored from the time of randomization until the end of the study. The expected duration of treatment in the study is 20 days, Regular evaluations are scheduled during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Difference in sTxB2 levels in subgroup of obese (BMI = 35) patients 2) Difference in platelet reactivity in subgroup of obese (BMI = 35) patients 3) Difference in sTxB2 levels in subgroup of non-obese patients 4) Difference in platelet reactivity in subgroup of non-obese patients 5) Difference in pharmacokinetics measured with % of maximal TxB2 inhibition (Imax) 6) Difference in pharmacokinetics measured with TxB2 AUC0-24 7) Safety assessment. The number of AE/SAE after twice daily ASA 50 mg tablets compared to once daily ASA 100 mg tablets. ;Timepoint(s) of evaluation of this end point: Secondary endpoints will be assessed throughout the study | — |
Countries
Poland
Contacts
Public ContactPunkt Informacyjny Badania
Adamed Pharma S.A.
Outcome results
None listed