NCT03465644CompletedPhase 4
TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI
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
Source: ClinicalTrials.gov · Last updated 6 Jun 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2018 (actual)
- First submitted
- 8 Mar 2018
- Start date
- 12 Feb 2019
- Primary completion date
- 13 Feb 2025
- Lead sponsor
- Duk-Woo Park, MD
- Diseases
- Coronary artery disease
- NCT number
- NCT03465644
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 2018
- From 12 Feb 2019 to the primary completion date, 13 Feb 2025
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
- Use of Gp IIb/IIIa inhibitors at randomization
- Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
- Planned surgery within 180 days
- 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
- 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
Other illness
- Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
- 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
- Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening
Lab values
- Platelet count \<80,000 cells/mm3 or hemoglobin level \<10 g/dL
Other
- Cardiogenic shock
- Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))
- At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)
- Pregnant and/or lactating women.
- Inability to provide written informed consent or participate in long-term follow-up
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hallym University Sacred Heart Hospital Coordinator of this site? Confirm its status | Anyang | South Korea | Unknown status |
| Soon Chun Hyang University Hospital Bucheon Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
| Gyeongsang National University Changwon hospital Coordinator of this site? Confirm its status | Changwon | South Korea | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheonju | South Korea | Unknown status |
| Gangwon National Univ. Hospital Coordinator of this site? Confirm its status | Chuncheon | South Korea | Unknown status |
| Daegu Catholic University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Gangneung Asan Hospital Coordinator of this site? Confirm its status | Gangneung | South Korea | Unknown status |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Dong-A Medical Center Coordinator of this site? Confirm its status | Pusan | South Korea | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Pusan | South Korea | Unknown status |
| Inje University Pusan Paik Hospital Coordinator of this site? Confirm its status | Pusan | South Korea | Unknown status |
| Bundang CHA Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Seoul university Bundang hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic Univ. of Korea Eunpyeong St. Mary's hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Yeouido St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| St.Carollo Hospital Coordinator of this site? Confirm its status | Suncheon | South Korea | Unknown status |
| The Catholic University of Korea, ST. Mary's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.