COMPARE STEMI ONE- Comparison Of reduced DAPT followed by P2Y12 inhibitor Monotherapy with Prasugrel vs tAndard Regimen in STEMI patients treated with OCT-guided vs aNgio-guided completE revascularization.

Conditions

St-Elevated Myocardial Infartion

Brief summary

- Net Adverse Clinical Events (NACE) Composite endpoint of cardiovascular deaths, myocardial infarction, stroke or bleeding BARC 3 or 5 at 11 months post DAPT randomization., - Post-procedural Minimal Stent Area (MSA) Final Post-PCI MSA assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.

Detailed description

Major Adverse Cerebrovascular Events (MACE) Composite endpoint of deaths, myocardial infarction or stroke at 2, 11 and 35 months, BARC type 3 or 5 at 2,11 and 35 months, Incidence of target vessel failure (TVF), the composite time-to-first event rate of death, target vessel myocardial infarction (TV-MI) (per-protocol MI definition), or ischemia-driven target vessel revascularization (ID-TVR) at 2, 11 and 35 months, Procedural outcomes OCT-defined (OCT core laboratory assessed). Subjects in the angiography-guided arm will undergo a post-PCI OCT run. Assessed per target lesion. 1. Stent expansion; 2. Mean stent expansion; 3. Edge dissection; 4.Stent Malapposition; 5.Border detection; 6.Untreated reference segmet disease, - Incidence of stent thrombosis (definite or probable as defined by the Academic Research Consortium

Related papers

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Interventions

DRUGPRASUGREL

DRUGACETYLSALICYLIC ACID

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
- Net Adverse Clinical Events (NACE) Composite endpoint of cardiovascular deaths, myocardial infarction, stroke or bleeding BARC 3 or 5 at 11 months post DAPT randomization., - Post-procedural Minimal Stent Area (MSA) Final Post-PCI MSA assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.	—

Secondary

Measure	Time frame
Major Adverse Cerebrovascular Events (MACE) Composite endpoint of deaths, myocardial infarction or stroke at 2, 11 and 35 months, BARC type 3 or 5 at 2,11 and 35 months, Incidence of target vessel failure (TVF), the composite time-to-first event rate of death, target vessel myocardial infarction (TV-MI) (per-protocol MI definition), or ischemia-driven target vessel revascularization (ID-TVR) at 2, 11 and 35 months, Procedural outcomes OCT-defined (OCT core laboratory assessed). Subjects in the angiography-guided arm will undergo a post-PCI OCT run. Assessed per target lesion. 1. Stent expansion; 2. Mean stent expansion; 3. Edge dissection; 4.Stent Malapposition; 5.Border detection; 6.Untreated reference segmet disease, - Incidence of stent thrombosis (definite or probable as defined by the Academic Research Consortium	—

Measure

Time frame

Major Adverse Cerebrovascular Events (MACE) Composite endpoint of deaths, myocardial infarction or stroke at 2, 11 and 35 months, BARC type 3 or 5 at 2,11 and 35 months, Incidence of target vessel failure (TVF), the composite time-to-first event rate of death, target vessel myocardial infarction (TV-MI) (per-protocol MI definition), or ischemia-driven target vessel revascularization (ID-TVR) at 2, 11 and 35 months, Procedural outcomes OCT-defined (OCT core laboratory assessed). Subjects in the angiography-guided arm will undergo a post-PCI OCT run. Assessed per target lesion. 1. Stent expansion; 2. Mean stent expansion; 3. Edge dissection; 4.Stent Malapposition; 5.Border detection; 6.Untreated reference segmet disease, - Incidence of stent thrombosis (definite or probable as defined by the Academic Research Consortium

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Countries

Belgium, Czechia, Germany, Italy, Netherlands

Outcome results

None listed