TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI (TAILORED-CHIP)

  • STATUS
    Recruiting
  • End date
    Dec 2, 2023
  • participants needed
    2000
  • sponsor
    Duk-Woo Park, MD
Updated on 28 February 2022
diabetes
aspirin
percutaneous coronary intervention

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).

Details
Condition Coronary Stenoses
Treatment Tailored antithrombotic strategy, Conventional antithrombotic strategy
Clinical Study IdentifierNCT03465644
SponsorDuk-Woo Park, MD
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

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
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