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)

Phase 1

• Conditions: Chronic ischemic cardiopathy; MedDRA version: 20.0Level: LLTClassification code 10032060Term: Other forms of chronic ischemic heart diseaseSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004157-33-IT
• Lead Sponsor: CENTRO CARDIOLOGICO SPA FONDAZIONE MONZINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

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

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).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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;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 Outcome Measures

Name	Time	Method
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