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Completed

NCT Number: NCT03465644

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

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).

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hallym University Sacred Heart Hospital, Anyang, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 19 and more
  • Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
  • Patients must have at least one of any features of complex high-risk anatomic, procedural, or clinical-related 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
  • The patient or guardian agreed to the study protocol and the schedule of clinical follow-up and provided informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.

Exclusion criteria

  • Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
  • Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
  • Use of Gp IIb/IIIa inhibitors at randomization
  • Cardiogenic shock
  • Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
  • Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))
  • 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 hemorrhage or intracranial aneurysm
  • Planned surgery within 180 days
  • Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening
  • Platelet count <80,000 cells/mm3 or hemoglobin level <10 g/dL
  • At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)
  • Use of strong cytochrome P-450 3A inhibitor or inducers within 2 week of the date of enrollment

: ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampin/rifampicin, rifabutin, dexamethasone, phenytoin, carbamazepine, phenobarbital

  • Pregnant and/or lactating women.
  • Concurrent medical condition with a life expectancy of less than 1 years
  • Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period
  • Inability to provide written informed consent or participate in long-term follow-up

Treatment and study plan

Tailored antithrombotic strategy

Drug

Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months

Conventional antithrombotic strategy

Drug

Clopidogrel + aspirin for 12months

Primary outcomes

  1. Net clinical outcome

    Time frame: 1 year

    a net clinical outcome of all-cause death, myocardial infarction, stroke, stent thrombosis, urgent revascularization or clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] at 12 months after randomisation

Secondary outcomes

  1. Death

    Time frame: 1 year

    Efficacy outcomes: any, cardiovascular, or non-cardiovascular cause death

  2. Myocardial infarction

    Time frame: 1 year

    Efficacy outcomes: any, periprocedural, or spontaneous Myocardial infarction

  3. Stroke

    Time frame: 1 year

    Efficacy outcomes: any, ischemic, or hemorrhagic Stroke

  4. Stent thrombosis

    Time frame: 1 year

    Efficacy outcomes

  5. The rate of unplanned urgent repeat revascularization

    Time frame: 1 year

    Efficacy outcomes: any, target-vessel, or non-target-vessel Repeat revascularisation

  6. Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization)

    Time frame: 1 year

    Efficacy outcomes

  7. Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke)

    Time frame: 1 year

    Efficacy outcomes

  8. BARC major bleeding (type 3 or 5 bleeding)

    Time frame: 1 year

    Safety outcomes: Bleeding Academic Research Consortium

  9. TIMI major or minor bleeding

    Time frame: 1 year

    Safety outcomes: Thrombolysis In Myocardial Infarction

  10. GUSTO moderate or severe bleeding

    Time frame: 1 year

    Safety outcomes: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries

  11. ISTH major bleeding

    Time frame: 1 year

    Safety outcomes: International Society of Thrombosis and Hemostasis; PCI, percutaneous coronary intervention

  12. Any major or minor bleeding

    Time frame: 1 year

    Safety outcomes

Sponsors and collaborators

Lead sponsor

Duk-Woo Park, MD

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

Comparison of Tailored Antiplatelet Therapy With Early Escalation and Late De-Escalation Strategy Versus Standard Dual Antiplatelet Therapy in Patients Undergoing Complex High-Risk Percutaneous Coronary Intervention

Acronym: TAILORED-CHIP

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2018
Registry last updated
Jun 6, 2025

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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