NCT05936606Recruiting
Tailored Anti-platelet Therapy After DES Implantation in High-risk Patients
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
Source: ClinicalTrials.gov · Last updated 30 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 3434 (estimated)
- First submitted
- 22 May 2023
- Start date
- Aug 2023
- Primary completion date
- May 2027
- Lead sponsor
- Yonsei University
- Diseases
- Coronary artery disease
- NCT number
- NCT05936606
What you commit to
- Study type: Interventional
- Planned participants: 3434
- From Aug 2023 to the primary completion date, May 2027
- 1 site 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
- Patients eligible to long-term anticoagulation therapy
- Patients with major bleeding events in previous 3 months before randomization
Age
- Patients \> 80 years old
Other
- Pregnant women or women with potential childbearing
- Life expectancy \< 1 year
- Refusal or inability to understand of informed consent
Who the study is looking for
- 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
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.