CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 4

NCT05066789 | Terminated Phase 4 DMC

• 1 other identifier: CHOICE-4
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is multi-center, open label, two-by-two factorial, randomized, noninferiority trial to compare the efficacy and safety of polymer-free cobalt-chromium thin drug-coated stents (BioFreedom Ultra) with biodegradable polymer ultrathin sirolimus-eluting stents (Orsiro Mission) and prasugrel monotherapy after 1-month dual antiplatelet therapy (DAPT) of aspirin plus prasugrel with 12-month DAPT of aspirin plus prasugrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention; Acute coronary syndrome; Antiplatelet Therapy; Drug eluting stent

Outcome Measures

Primary Outcomes (2)

• Stent Comparison Study: target-lesion failure (TLF)

  a composite of cardiac death, target vessel-myocardial infarction, or clinically indicated target-lesion revascularization by percutaneous or surgical methods

  1 year

• Antiplatelet Comparison Study: net adverse clinical events (NACE)

  a composite of major adverse cardiac and cerebrovascular events (MACCE) and clinically relevant bleeding

  1 year

Secondary Outcomes (26)

• Stent Comparison Study: TLF

  3 years

• Stent Comparison Study: target-vessel failure

  1 and 3 years

• Stent Comparison Study: cardiac death

  1 and 3 years

• Stent Comparison Study: target-vessel myocardial infarction (MI)

  1 and 3 years

• Stent Comparison Study: clinically indicated TLR

  1 and 3 years

Study Arms (4)

Biodegradable Polymer DES

ACTIVE COMPARATOR

Patients will be randomized to either the polymer-free drug-coated stent (DCS) group or the biodegradable polymer drug-eluting (DES) group with 1:1 ratio. This group will use Orsiro Mission stent during the index procedure.

Device: Type of stent

12-month DAPT

ACTIVE COMPARATOR

Patients will be randomized to either the prasugrel monotherapy group or the 12-month dual antiplatelet therapy (DAPT) group with 1:1 ratio unless patients have additional exclusion criteria for antiplatelet study. This group will receive 12-month DAPT of aspirin (100mg once daily) plus prasugrel (10mg once daily).

Drug: Duration of DAPT

Polymer-free DCS

EXPERIMENTAL

Patients will be randomized to either the polymer-free drug-coated stent (DCS) group or the biodegradable polymer drug-eluting (DES) group with 1:1 ratio. This group will use BioFreedom Ultra stent during the index procedure.

Device: Type of stent

Prasugrel monotherapy

EXPERIMENTAL

Patients will be randomized to either the prasugrel monotherapy group or the 12-month dual antiplatelet therapy (DAPT) group with 1:1 ratio unless patients have additional exclusion criteria for antiplatelet study. This group will receive aspirin (100mg once daily) plus prasugrel (10mg once daily) for 1 month and thereafter prasugrel (10mg once daily) alone.

Drug: Duration of DAPT

Interventions

Type of stent DEVICE

1:1 randomization to biodegradable polymer DES (Orsiro Mission) and polymer-free DCS (Biofreedom)

Biodegradable Polymer DES; Polymer-free DCS

Duration of DAPT DRUG

1:1 randomization to 1-month DAPT thereafter prasugrel monotherapy and 12-month DAPT (aspirin + prasugrel)

12-month DAPT; Prasugrel monotherapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 19 years of age
• Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
• Patients presenting with ACS (ST-elevation myocardial infarction \[STEMI\], non-ST-elevation myocardial infarction \[NSTEMI\], or unstable angina)
• Patients with at least one lesion with equal or greater than 50% diameter stenosis requiring treatment with drug-eluting stents (DES) in native coronary artery or graft

You may not qualify if:

• Patients unable to provide consent
• Patients with known intolerance to aspirin, clopidogrel, prasugrel, or major components of drug-eluting stents
• Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
• Patients who need chronic anti-coagulation therapy
• Patients with active pathological bleeding
• Pregnant or lactating women
• Patients with history of stroke or transient ischemic attack
• Patients 75 years of age or older
• Patients weighing less than 60 kg

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Joo-Yong Hahn, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

Study Design

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

Model Details: multi-center, open label, two-by-two factorial, randomized, noninferiority trial

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 4, 2021
• Study Start: January 17, 2022
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)