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Comparing high and lOw-dose asPirin with dual anTIplatelet therapy for three Months using prasUgrel and aSpirin following Coronary Artery Bypass Grafting. (OPTIMUS-CABG trial).

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521892-30-00
Acronym
2024/ABM/01/00016
Enrollment
1703
Registered
2025-09-08
Start date
2025-11-24
Completion date
Unknown
Last updated
2025-11-21

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

Conditions

Primary isolated CABG patients with stable coronary artery disease (chronic coronary syndrome) planned for at least 2 grafts.

Brief summary

The assessment of the proportion of failed grafts is defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG procedure in patients with DAPT with prasugrel (10mg/day) plus ASA (75mg/day) vs high-dose ASA (300mg/d) and DAPT vs low-dose ASA (75mg/day)

Detailed description

The assessment of the proportion of failed grafts defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG procedure, in patients receiving high- (300mg/d) vs low-dose ASA (75mg/day)., A safety and efficacy assessment of use of the investigational products, based on the frequency of reported adverse events during the first 6 and 12 and long term follow up months after randomization., a) All-cause mortality at 12 months in the three groups, b) Incidence of myocardial infarction in the three groups, c) Incidence of stroke in the three groups, d) Incidence of repeat revascularization in the three groups, e) Incidence of MACCE (composite mortality, myocardial infarction, stroke and repeat revascularization) at 12 months and beyond 12 months in the three groups, f) Safety of treatment in terms of the incidence of bleeding within 12 months according to the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 in three groups., g) Quality of life questionnaires evaluated using SAQ 7 and SF 12., Safety of short-term use of the investigational product - assessment until 12 weeks from randomization visit based on the frequency of reported adverse events (AE, AESI, SAE) – type, grading, relationship to prasugrel /ASA.

Interventions

DRUGACETYLSALICYLIC ACID
DRUGPRASUGREL

Sponsors

Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The assessment of the proportion of failed grafts is defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG procedure in patients with DAPT with prasugrel (10mg/day) plus ASA (75mg/day) vs high-dose ASA (300mg/d) and DAPT vs low-dose ASA (75mg/day)

Secondary

MeasureTime frame
The assessment of the proportion of failed grafts defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG procedure, in patients receiving high- (300mg/d) vs low-dose ASA (75mg/day)., A safety and efficacy assessment of use of the investigational products, based on the frequency of reported adverse events during the first 6 and 12 and long term follow up months after randomization., a) All-cause mortality at 12 months in the three groups, b) Incidence of myocardial infarction in the three groups, c) Incidence of stroke in the three groups, d) Incidence of repeat revascularization in the three groups, e) Incidence of MACCE (composite mortality, myocardial infarction, stroke and repeat revascularization) at 12 months and beyond 12 months in the three groups, f) Safety of treatment in terms of the incidence of bleeding within 12 months according to the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 in three grou

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026