TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duk-Woo Park, MD
• Collaborator: CardioVascular Research Foundation, Korea
• Treatments: Aspirin; Clopidogrel

Criteria

Inclusion Criteria:

• Age 19 and more

• Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent

• at least one of the following high-risk clinical, lesion or procedure-related risk factors;

• Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance <60 mL/min), or low left ventricular ejection fraction (<40%) or

• Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, diffuse long lesion (lesion length ≥ at least 30 mm), multi-vessel PCI (≥ 2 vessels requiring stent implantation), ≥3 requiring stent implantation, ≥ 3 lesions will be treated, or predicted total stent length for revascularization > 60 mm

Exclusion Criteria:

• Enzyme-positive ACS (NSTEMI or STEMI)

• Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)

• Cardiogenic shock at the index admission

• Treated with only bare metal stent or balloon angioplasty during the index procedure

• Need for chronic oral anticoagulation

• Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)

• History of intracranial haemorrhage or intracranial aneurysm

• Planned surgery within 180 days

• Liver cirrhosis

• Dialysis-dependent renal failure

• Pregnant and/or lactating women

• Concurrent medical condition with a life expectancy of less than 1 years

• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period

• Unable to provide written informed consent or participate in long-term follow-up