NCT04014803 Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion
| NCT ID | NCT04014803 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Samsung Medical Center |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,500 participants |
| Start Date | 2020-01-13 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,500 participants in total. It began in 2020-01-13 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Joo-Yong Hahn, MD, PhD
STUDY CHAIR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT04014803 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 75 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04014803 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04014803 currently recruiting?
Yes, NCT04014803 is actively recruiting participants. Contact the research team at ichjy1@gmail.com for enrollment information.
Where is the NCT04014803 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT04014803 clinical trial?
NCT04014803 is sponsored by Samsung Medical Center. The principal investigator is Joo-Yong Hahn, MD, PhD at Samsung Medical Center. The trial plans to enroll 3,500 participants.