To evaluate the effect and tollerability of 2 different formulations of acetylsalicylic acid of which one associated with 200mg of triglycerides of n-3 series fatty acids (omega 3 + ASA)

Effect of the administration of 75 mg of acetylsalicylic acid + 200mg of triglycerides of n-3 series fatty acids (omega 3 + ASA) on the biosynthesis of platelet thromboxane A2 in patients with cardiovascular disease. - NASA (n-3 and ASA in patients with Stable Angina)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004157-33-IT

Enrollment

Registered

2021-06-08

Start date

2021-05-12

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Chronic ischemic cardiopathy MedDRA version: 20.0 Level: LLT Classification code 10032060 Term: Other forms of chronic ischemic heart disease System Organ Class: 100000004849

Interventions

Trade Name: CARDIORAL - 75 MG CAPSULE MOLLI 30 CAPSULE IN BLISTER PCTFE/AL Product Name: CARDIORAL Pharmaceutical Form: Capsule, soft INN or Proposed INN: ACIDO SALICILICO Current Sponsor code: CARDIO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with stable coronary heart disease, aged between 18 and 80 years, already treatrd with ASA 100 mg for at least one month. 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 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: The exclusion criteria are: a percutaneous angioplasty or acute coronary syndrome in the month prior to randomization; treatment with inhibitors of glycoprotein IIb / IIIa or thrombolytics agents in the month prior to randomization; concomitant treatment with products containing fatty acids of the n-3 series; concomitant treatment with ibuprofen, naproxen, or warfarin; thrombocytopenia (platelet count =100x103 cells / mm3); anemia (hemoglobin =10 g / dl); renal impairment (creatinine 2.5 mg / dl).

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate if treatment with of 75 mg of acetylsalicylic acid + 200 mg of n-3 fatty acids (omega 3 + ASA) is able to inhibit platelet COX-1 in vivo, in a similar way as the treatment with 100 mg acetylsalicylic acid (non inferiority limit of 6.7%).;Secondary Objective: Evaluation of tolerability (pro-haemorragic effect and "coronary instability" of treatments. Evaluation of the efficacy (anti-platelet effect) on platelet COX 1 inhibition ex vivo;Primary end point(s): Evaluate the efficacy (antiplatelet effect) of Cardioral (75 mg ASA + 200 mg omega-3) in inhibiting platelet COX-1;Timepoint(s) of evaluation of this end point: before treatment and afterwards on days 1, 7, 36, 60 e 90 of treatment	—

Measure

Time frame

Main Objective: Evaluate if treatment with of 75 mg of acetylsalicylic acid + 200 mg of n-3 fatty acids (omega 3 + ASA) is able to inhibit platelet COX-1 in vivo, in a similar way as the treatment with 100 mg acetylsalicylic acid (non inferiority limit of 6.7%).;Secondary Objective: Evaluation of tolerability (pro-haemorragic effect and "coronary instability" of treatments. Evaluation of the efficacy (anti-platelet effect) on platelet COX 1 inhibition ex vivo;Primary end point(s): Evaluate the efficacy (antiplatelet effect) of Cardioral (75 mg ASA + 200 mg omega-3) in inhibiting platelet COX-1;Timepoint(s) of evaluation of this end point: before treatment and afterwards on days 1, 7, 36, 60 e 90 of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): monitoring for haemorragic effects or coronary instability ;Timepoint(s) of evaluation of this end point: during the whole duration of the study and in particular on days 1, 7, 36, 60 e 90 of treatment	—

Countries

Italy

Contacts

Public ContactUFFICIO STUDI CLINICI E ATTIV. REGO

ISTITUTO EUROPEO ONCOLOGIA

ufficio.studiclinici@ieo.it0257489848

Outcome results

None listed

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