NCT04014803

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
32mo left

Started Jan 2020

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2020Dec 2028

First Submitted

Initial submission to the registry

July 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

7.5 years

First QC Date

July 8, 2019

Last Update Submit

February 6, 2026

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary InterventionDual Antiplatelet TherapyComplex Coronary Lesion

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events (MACE)

    A composite of death, myocardial infarction, or stent thrombosis

    1-year after randomization

Secondary Outcomes (17)

  • All-cause death

    1-year after randomization

  • Cardiac death

    1-year after randomization

  • Myocardial infarction

    1-year after randomization

  • Stent thrombosis

    1-year after randomization

  • Target lesion revascularization

    1-year after randomization

  • +12 more secondary outcomes

Study Arms (2)

Prasugrel plus Aspirin arm

ACTIVE COMPARATOR

Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of prasugrel 60 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus prasugrel 10 mg once daily\* will be given for one year. \* Based on previous studies including PRASFIT-ACS (PRASugrel compared with clopidogrel For Japanese patIenTs with ACS undergoing PCI) or TRILOGY ACS (The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes), maintenance dose can be reduced to 5 mg once daily in patients with high bleeding risk or by investigator's medical judgement.

Drug: Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin

Clopidogrel plus Aspirin arm

ACTIVE COMPARATOR

Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of clopidogrel 600 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for one year.

Drug: Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin

Interventions

Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirinDRUG

Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin will be given according to the allocated arms in patients undergoing elective percutaneous coronary intervention for complex coronary lesion 1. Prasugrel plus Aspirin arm 2. Clopidogrel plus Aspirin arm

Also known as: Prasugrel plus Aspirin or Clopidogrel plus Aspirin
Clopidogrel plus Aspirin armPrasugrel plus Aspirin arm

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

AspirinPrasugrel HydrochlorideClopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsThiophenesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTiclopidineThienopyridinesPyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Joo-Yong Hahn, MD, PhD

    Samsung Medical Center

    STUDY CHAIR

Central Study Contacts

Joo-Yong Hahn, MD, PhD

CONTACT

82-2-3410-1246ichjy1@gmail.com

Ki hong Choi, MD, PhD

CONTACT

82-2-3410-3419cardiokh@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 10, 2019

Study Start

January 13, 2020

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

KR(2)