Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI (DEBATE)

Conditions

Coronary artery disease

Brief summary

The primary endpoint is the composite of MACE and BARC (Bleeding academic research consortium) type 2-5 bleeding episodes at 12 months. Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR)

Detailed description

The composite of MACE and BARC2-5 bleedings (24 and 36 months), MACE 12, 24 and 26 months, BARC2-5 bleedings 12, 24 and 26 months, BARC3-5 bleedings 12, 24 and 26 months, Total mortality 12, 24 and 26 months, Cardiovascular mortality 12, 24 and 26 months, Myocardial infarction 12, 24 and 26 months, TLR 12, 24 and 26 months, Target-vessel failure (TVF) 12, 24 and 26 months, Target-lesion failure (TLF) 12, 24 and 26 months, The composite of TLR and BARC2-5 bleedings 12, 24 and 26 months, The composite of TVF and BARC2-5 bleedings 12, 24 and 26 months, The composite of TLF and BARC2-5 bleedings 12, 24 and 26 months, The composite of TLR and BARC3-5 bleedings 12, 24 and 26 months, Acute vessel closure as defined by the consensus criteria for definite/probable stent thrombosis, Hospitalization for urgent revascularization, Stroke (ischemic or hemorrhagic) or TIA 12, 24 and 26 months

Related papers

No related papers found yet.

Interventions

DRUGASPIRIN CARDIO 100 mg comprimate gastrorezistente

DRUGEfient 10 mg film-coated tablets.

DRUGBrilique 90 mg film-coated tablets

DRUGPlavix 75 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the composite of MACE and BARC (Bleeding academic research consortium) type 2-5 bleeding episodes at 12 months. Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR)	—

Secondary

Measure	Time frame
The composite of MACE and BARC2-5 bleedings (24 and 36 months), MACE 12, 24 and 26 months, BARC2-5 bleedings 12, 24 and 26 months, BARC3-5 bleedings 12, 24 and 26 months, Total mortality 12, 24 and 26 months, Cardiovascular mortality 12, 24 and 26 months, Myocardial infarction 12, 24 and 26 months, TLR 12, 24 and 26 months, Target-vessel failure (TVF) 12, 24 and 26 months, Target-lesion failure (TLF) 12, 24 and 26 months, The composite of TLR and BARC2-5 bleedings 12, 24 and 26 months, The composite of TVF and BARC2-5 bleedings 12, 24 and 26 months, The composite of TLF and BARC2-5 bleedings 12, 24 and 26 months, The composite of TLR and BARC3-5 bleedings 12, 24 and 26 months, Acute vessel closure as defined by the consensus criteria for definite/probable stent thrombosis, Hospitalization for urgent revascularization, Stroke (ischemic or hemorrhagic) or TIA 12, 24 and 26 months	—

Measure

Time frame

The composite of MACE and BARC2-5 bleedings (24 and 36 months), MACE 12, 24 and 26 months, BARC2-5 bleedings 12, 24 and 26 months, BARC3-5 bleedings 12, 24 and 26 months, Total mortality 12, 24 and 26 months, Cardiovascular mortality 12, 24 and 26 months, Myocardial infarction 12, 24 and 26 months, TLR 12, 24 and 26 months, Target-vessel failure (TVF) 12, 24 and 26 months, Target-lesion failure (TLF) 12, 24 and 26 months, The composite of TLR and BARC2-5 bleedings 12, 24 and 26 months, The composite of TVF and BARC2-5 bleedings 12, 24 and 26 months, The composite of TLF and BARC2-5 bleedings 12, 24 and 26 months, The composite of TLR and BARC3-5 bleedings 12, 24 and 26 months, Acute vessel closure as defined by the consensus criteria for definite/probable stent thrombosis, Hospitalization for urgent revascularization, Stroke (ischemic or hemorrhagic) or TIA 12, 24 and 26 months

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Countries

Finland, France, Spain

Outcome results

None listed