Comparing two treatments for patients with complex coronary lesions undergoing PCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of dual antiplatelet therapy using aspirin combined with prasugrel versus aspirin combined with clopidogrel in patients undergoing elective percutaneous coronary intervention (PCI) for complex coronary lesions. It is a prospective, open-label, two-arm, randomized multicenter trial aimed at reducing ischemic events in this high-risk population. The study will assess the optimal duration of treatment and the potential benefits of using a more potent P2Y12 inhibitor in conjunction with aspirin. Participants will be monitored for ischemic events and safety outcomes over the course of the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ① Subject must be at least 19 years of age
* ② Subject who can verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
* ③ Patients undergoing elective PCI as follows:

  1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5 mm size
  2. Chronic total occlusion (≥3 months) as target lesion
  3. PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions)
  4. Long coronary lesions (expected stent length ≥38 mm)
  5. Multi-vessel PCI (≥2 vessels treated at one PCI session)
  6. Multiple stent needed (≥3 stents per patient)
  7. In-stent restenosis lesion as target lesion
  8. Severely calcified lesion (encircling calcium in angiography)
  9. Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery

Exclusion Criteria:

* ① Hemodynamic instability or cardiogenic shock
* ② Subjects with serious bleeding (Intracerebral hemorrhage, gastrointestinal bleeding, hematuria, hemoptysis, and etc.)
* ③ Previous history of intracerebral hemorrhage, transient ischemic attack, or stroke
* ④ Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel, and prasugrel)
* ⑤ Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
* ⑥ Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
* ⑦ Patients presenting with biomarker positive acute coronary syndrome
* ⑧ Patients chronically taking prasugrel or ticagrelor (≥1 week)
* ⑨ Subjects ≥75 years of age or \<60 kg of body weight
* ⑩ Patients taking warfarin or novel oral anticoagulants (dabigatran, rivaroxaban, edoxaban, or apixaban)

  * Eligible patients will be randomly assigned to treatment arms, stratified by participating centers, presence of diabetes mellitus, and stent types.

Where it's running

• Samsung Medical Center
  Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Joo-Yong Hahn, MD, PhD
• Email: ichjy1@gmail.com
• Phone: 82-2-3410-1246

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.