A Randomized Comparison of TAILOReD Anti-Platelet Therapy According to Platelet Reactivity Versus Uniform Clopidogrel Monotherapy Beyond 12 Months After Drug-eluting Stent Implantation in High-risk Patients: TAILOR-DAPT

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Clopidogrel monotherapy has been found effective in reducing ischaemic cardiovascular and haemorrhagic complications in patients with drug-eluting stent (DES) placement. However, concerns remain about the safety of long-term clopidogrel monotherapy in high-risk patients with HPR (high platelet reactivity) who do not respond adequately to clopidogrel. This study aims to evaluate the effectiveness of a patient-tailored antiplatelet therapy strategy that considers platelet aggregation in high-risk patients with DES placement beyond 12 months after stenting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients \> 18 years old

• Patients who previously underwent percutaneous coronary intervention with drug-eluting stent implantation 12 months (± 3 months) ago.

• At least one high risk characteristics of ischemic events

⁃ High risk patients

• Acute coronary syndrome

• Previous history of cerebrovascular accidents

• Previous history of peripheral artery intervention

• Heart failure

• Diabetes mellitus requiring medication

• Chronic kidney disease (regardless of requirement of renal replacement therapy)

⁃ High risk lesions

• Left main disease

• Multivessel disease, 2- or 3- vessels

• Bifurcation lesions requiring 2 or more stents

• Chronic total occlusion

• In-stent restenosis

• Graft lesions

• Diffuse long lesion requiring stent(s) with total stent length ≥28 mm

• Lesion at small sized vessel requiring stent(s) with stent diameter ≤2.5 mm

• Calcified lesions requiring atherectomy

Locations
Other Locations
Republic of Korea
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Byeong-Keuk Kim
kimbk@yuhs.ac
02-2228-8465
Time Frame
Start Date: 2023-08-16
Estimated Completion Date: 2029-05
Participants
Target number of participants: 3434
Treatments
Active_comparator: Uniform Therapy
Patients will continue clopidogrel monotherapy for 24 months from randomization, irrespective of their PRU measurement.
Experimental: Tailored Therapy
Patients in the intervention arm will receive tailored anti-platelet therapy according to PRU and bleeding risk
Related Therapeutic Areas
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov