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NCT Number: NCT05936606

Tailored Anti-platelet Therapy After DES Implantation in High-risk Patients

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.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study will randomly assign eligible participants who underwent drug-eluting stent placement and have maintained the standard antiplatelet therapy for 12 months to either a control group or an intervention group. The control group will continue receiving clopidogrel monotherapy for 24 months regardless of their PRU (platelet reactivity unit) values. The intervention group will receive personalized antiplatelet therapy based on their PRU values: for non-HPR patients (PRU<208), clopidogrel monotherapy will be continued; for HPR patients (PRU≥208), dual antiplatelet therapy will be prescribed based on clinical diagnosis at the time of stent implantation and individual patients' ischemic/bleeding risk profiles. Patients (≥50 years) who presented with acute myocardial infarction at the time of coronary intervention, and have high-risk characteristics (① ≥65 years ② multi-vessel disease ③ diabetes mellitus ④ chronic kidney disease ⑤ recurrent myocardial infarction) will receive ticagrelor 60 mg twice daily with aspirin, whereas the remainder will receive clopidogrel with aspirin. For high-bleeding-risk patients with two or more major bleeding risk factors according to ARC-HBR, the investigator may consider early discontinuation of dual antiplatelet therapy or de-escalation therapy like aspirin monotherapy based on the patient's risk profile. The treatment assignment ratio is 1:1. The study period will be up to 24 months from the time of randomization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients > 80 years old
  • Pregnant women or women with potential childbearing
  • Life expectancy < 1 year
  • Refusal or inability to understand of informed consent
  • Patients eligible to long-term anticoagulation therapy
  • Patients with major bleeding events in previous 3 months before randomization

Treatment and study plan

Clopidogrel monotherapy

Drug

Patients will receive clopidogrel monotherapy (75 mg qd) for 24 months after randomization, irrespective of PRU value or bleeding risk.

Tailored anti-platelet therapy

Drug

In the tailored therapy arm, non-HPR (PRU<208) patients will continue clopidogrel monotherapy until the end of the study at 24 months from randomization, while HPR (PRU≥208) patients will receive dual anti-platelet therapy according to the clinical diagnosis at the time of drug-eluting stent placement: High-risk patients with prior myocardial infarction will receive ticagrelor 60 mg twice daily wiht aspirin 100 mg daily, while the remainder will receive clopidogrel 75 mg daily with aspirin 100 mg daily. For HBR patietns, early cessation of dual antiplatelet therapy or aspirin monotherapy could be considered at the investigator's discretion.

Primary outcomes

  1. Net Clinical Adverse Clinical Events (NACE) for 24 months

    Time frame: upto 2 years after randomization

    A composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or BARC type 2, 3, or 5 bleeding

Secondary outcomes

  1. All-cause death

    Time frame: upto 2 years after randomization

  2. Cardiovascular death

    Time frame: upto 2 years after randomization

  3. Myocardial infarction

    Time frame: upto 2 years after randomization

  4. Stent thrombosis

    Time frame: upto 2 years after randomization

  5. Ischemia-driven target vessel revascularization

    Time frame: upto 2 years after randomization

  6. Any revascularization

    Time frame: upto 2 years after randomization

  7. Stroke

    Time frame: upto 2 years after randomization

  8. Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding

    Time frame: upto 2 years after randomization

  9. Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding

    Time frame: upto 2 years after randomization

  10. Bleeding Academic Research Consortium (BARC) type 2 bleeding

    Time frame: upto 2 years after randomization

  11. Bleeding Academic Research Consortium (BARC) type 3 bleeding

    Time frame: upto 2 years after randomization

  12. Bleeding Academic Research Consortium (BARC) type 5 bleeding

    Time frame: upto 2 years after randomization

  13. All-cause death, myocardial infarction, or stroke

    Time frame: upto 2 years after randomization

  14. Cardiovascular death, myocardial infarction, stent thrombosis, or stroke

    Time frame: upto 2 years after randomization

  15. All-cause death, myocardial infarction, stent thrombosis, stroke, or BARC type 3 or 5 bleeding

    Time frame: upto 2 years after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Byeong-Keuk Kim

CONTACT

[email protected]

02-2228-8465

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Jul 10, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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