Actively Recruiting

Phase 4
Age: 19Years - 75Years
All Genders
NCT04014803

Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion

Led by Samsung Medical Center · Updated on 2026-02-09

3500

Participants Needed

2

Research Sites

467 weeks

Total Duration

On this page

Sponsors

S

Samsung Medical Center

Lead Sponsor

I

Inje University Ilsan Paik Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a prospective, open label, two-arm, randomized multicenter trial to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective percutaneous coronary intervention with drug eluting stents for complex coronary lesions.

CONDITIONS

Official Title

Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion

Who Can Participate

Age: 19Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 19 years old
  • Able to verbally confirm understanding of risks, benefits, and treatment alternatives and provide written informed consent
  • Undergoing elective PCI for complex coronary lesions including true bifurcation lesions with side branch 5.5 mm, chronic total occlusion of at least 3 months, unprotected left main disease, long coronary lesions with expected stent length 38 mm, multi-vessel PCI with 2 or more vessels treated in one session, multiple stents needed (3 or more), in-stent restenosis lesion, severely calcified lesion, or ostial lesions of major coronary arteries
Not Eligible

You will not qualify if you...

  • Hemodynamic instability or cardiogenic shock
  • History of serious bleeding events such as intracerebral hemorrhage, gastrointestinal bleeding, hematuria, or hemoptysis
  • Previous intracerebral hemorrhage, transient ischemic attack, or stroke
  • Known allergy or contraindication to aspirin, clopidogrel, or prasugrel
  • Females of childbearing potential without a recent negative pregnancy test or planning pregnancy after enrollment
  • Non-cardiac conditions with life expectancy less than 1 year or likely to cause non-compliance
  • Patients with biomarker positive acute coronary syndrome
  • Chronic use of prasugrel or ticagrelor for 1 week or more
  • Age 75 or older or body weight less than 60 kg
  • Current use of warfarin or novel oral anticoagulants such as dabigatran, rivaroxaban, edoxaban, or apixaban

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

2

Samsung Medical Center

Seoul, South Korea

Actively Recruiting

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Research Team

J

Joo-Yong Hahn, MD, PhD

CONTACT

K

Ki hong Choi, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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