Therapeutic Equivalence Study of Twice Daily Acetylsalicylic Acid Tablets 50 mg Compared to Once Daily Acetylsalicylic Acid Tablets 100 mg in Adult Patients Coronary Artery Disease (CAD) or Symptomatic Peripheral Artery Disease (PAD) or after Acute Coronary Syndrome (ACS)

Phase 1

• Conditions: Coronary Artery Disease (CAD) or Symptomatic Peripheral Artery Disease (PAD) or after Acute Coronary Syndrome (ACS); MedDRA version: 20.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 21.1Level: LLTClassification code 10067825Term: Peripheral arterial diseaseSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2023-000135-76-PL
• Lead Sponsor: Adamed Pharma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-06
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

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

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 <7 days before randomization
4.patients treated with heparin (including perioperative heparin) in the period <1 day before randomization and during the course of the study
5.indication for the use of low-molecular-weight heparin (LMWH)
6.concurrent administration of drugs that are potent inhibitors of Cytochrome P450 3A (CYP 3A)
7.recent antiplatelet treatment (< 30 days) with a glycoprotein IIb/IIIa antagonist;
8.history of gastrointestinal bleeding within the last 6 months;
9.history of cerebrovascular accident within the last 3 months;
10.active bleeding or hemodynamic instability;
11.any active malignancy recent surgery (within one month) including central nervous system (CNS) surgeries like lumbar puncture;
12.baseline ALT >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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified