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Coronary Artery DiseasePhase 4SMART-CHOICE4NCT05066789

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

A Phase 4 study testing Type of stent and Duration of DAPT in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Type of stent and Duration of DAPT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSouth Korea
Study dates
17 Jan 2022to 22 Mar 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Additional Exclusion Criteria for Antiplatelet Comparison Study:
  • Patients with history of stroke or transient ischemic attack
  • Patients 75 years of age or older
  • Patients weighing less than 60 kg

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: Comparison of Polymer-Free Cobalt-Chromium Thin Drug-Coated Stents With Biodegradable Polymer Ultrathin Sirolimus-Eluting Stents and Prasugrel Monotherapy With Conventional 12-Month Dual Antiplatelet Therapy

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.

Read the detailed description

Polymer is the key component of drug-eluting stents (DES) for facilitation of drug loading and control of drug release. However, durable polymer of the 1st generation DES has been considered to induce inflammation and to be associated with fatal complications such as very late stent thrombosis. To overcome this shortcoming, biodegradable polymer has been applied to the DES system. In several head-to-head comparison, ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent demonstrated comparable or superior outcomes compared with durable polymer everolimus-eluting stents. As a result, Orsiro stent is considered one of the standard contemporary DESs.

On the other hand, polymer-free drug-coated stents (DCS) have been developed as an alternative to durable and biodegradable polymer DES. The biolimus A9-coated BioFreedom stent is the representative polymer-free drug-coated stent and was superior to a bare-metal stent in patients treated with 1-month dual antiplatelet therapy (DAPT). However, it failed to show noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population, mainly due to increased target lesion revascularization (TLR). On top of possible insufficient or uncontrolled drug delivery at stented site due to absence of a drug carrier, thick strut (112 µm) and stainless steel alloy may explain a higher rate of TLR in the BioFreedom stent group compared with the Orsiro stent group. The BioFreedom Ultra stent is a novel cobalt-chromium thin stent (84 µm) with biolimus A9-coating. With advancement in stent alloy and strut thickness, treatment efficacy and safety of the BioFreedom Ultra stent would be comparable to the new version of Orsiro stent (Orsiro Mission) among patients with acute coronary syndrome (ACS).

Patients with ACS undergoing percutaneous coronary intervention (PCI) with DES are currently recommended to use 12 months of DAPT, consisting of aspirin and P2Y12 inhibitor. Although use of DAPT reduces ischemic events, including stent thrombosis, bleeding events increase in return. Hence, considering the aforementioned advancement of stent devices, shorter duration of DAPT and switching to a potent P2Y12 inhibitor monotherapy would be possible. This has been demonstrated in several recent studies. However, although prasugrel was superior to ticagrelor in lowering ischemic events, these studies mainly used ticagrelor as a solely used antiplatelet agent, and studies verifying the effect of prasugrel monotherapy after short duration of DAPT are limited to date. In addition, in these studies, DAPT was maintained for mostly at least 3 months in the ACS situation. With advancement of devices, duration of DAPT may be further reduced. In other words, prasugrel monotherapy after 1 month of DAPT of aspirin plus prasugrel would be comparable to 12-month DAPT of aspirin plus prasugrel.

Being tested
Type of stent, Duration of DAPT
Keywords
Percutaneous Coronary Intervention, Acute coronary syndrome, Antiplatelet Therapy, Drug eluting stent
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Type of stentDevice

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

  • Duration of DAPTDrug

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

Study groups in NCT05066789
Study groupRoleWhat they receive
Biodegradable Polymer DESActive comparatorPatients 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.
Receives: Device: Type of stent
12-month DAPTActive comparatorPatients 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).
Receives: Drug: Duration of DAPT
Polymer-free DCSExperimentalPatients 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.
Receives: Device: Type of stent
Prasugrel monotherapyExperimentalPatients 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.
Receives: Drug: Duration of DAPT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 year

  2. Antiplatelet Comparison Study: net adverse clinical events (NACE)

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

    Measured: 1 year

Secondary outcomes (26)
  1. Stent Comparison Study: TLF

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

    Measured: 3 years

  2. Stent Comparison Study: target-vessel failure

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

    Measured: 1 and 3 years

  3. Stent Comparison Study: cardiac death

    cardiac death

    Measured: 1 and 3 years

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

    target-vessel MI

    Measured: 1 and 3 years

  5. Stent Comparison Study: clinically indicated TLR

    clinically indicated TLR

    Measured: 1 and 3 years

  6. Stent Comparison Study: stent thrombosis

    definite or probable by Academic Research Consortium [ARC] definition

    Measured: 1 and 3 years

  7. Stent Comparison Study: clinically indicated target-vessel revascularization (TVR)

    clinically indicated target-vessel revascularization (TVR)

    Measured: 1 and 3 years

  8. Stent Comparison Study: cardiac death or MI

    cardiac death or MI

    Measured: 1 and 3 years

  9. Stent Comparison Study: cardiac death, MI, or stent thrombosis

    cardiac death, MI, or stent thrombosis

    Measured: 1 and 3 years

  10. Stent Comparison Study: all-cause death

    all-cause death

    Measured: 1 and 3 years

  11. Stent Comparison Study: MI

    MI

    Measured: 1 and 3 years

  12. Stent Comparison Study: all-cause death or MI

    all-cause death or MI

    Measured: 1 and 3 years

  13. Stent Comparison Study: any revascularization

    any revascularization

    Measured: 1 and 3 years

  14. Stent Comparison Study: restricted mean survival time for the TLF

    restricted mean survival time for the TLF

    Measured: 1 and 3 years

  15. Antiplatelet Comparison Study: MACCE

    a composite of all-cause death, MI, and stroke

    Measured: 1 year

  16. Antiplatelet Comparison Study: clinically relevant bleeding

    bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding

    Measured: 1 year

  17. Antiplatelet Comparison Study: all-cause death

    all-cause death

    Measured: 1 year

  18. Antiplatelet Comparison Study: MI

    MI

    Measured: 1 year

  19. Antiplatelet Comparison Study: stroke

    stroke

    Measured: 1 year

  20. Antiplatelet Comparison Study: cardiac death

    cardiac death

    Measured: 1 year

  21. Antiplatelet Comparison Study: stent thrombosis

    definite or probable by ARC definition

    Measured: 1 year

  22. Antiplatelet Comparison Study: all-cause death or MI

    all-cause death or MI

    Measured: 1 year

  23. Antiplatelet Comparison Study: cardiac death or MI

    cardiac death or MI

    Measured: 1 year

  24. Antiplatelet Comparison Study: cardiac death, MI, or stent thrombosis

    cardiac death, MI, or stent thrombosis

    Measured: 1 year

  25. Antiplatelet Comparison Study: BARC type 3 or 5 bleeding

    BARC type 3 or 5 bleeding

    Measured: 1 year

  26. Antiplatelet Comparison Study: restricted mean survival time for the NACE

    restricted mean survival time for the NACE

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start17 Jan 2022
  3. Primary completion22 Mar 2024
  4. Study completion22 Mar 2024

Why it stopped: Ending early registration due to low registration status and lack of research

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
multi-center, open label, two-by-two factorial, randomized, noninferiority trial
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05066789
Sponsor's protocol ID
CHOICE-4
Acronym
SMART-CHOICE4
Status last verified
May 2025
First submitted
15 Sep 2021
Last updated
18 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Type of stent and Duration of DAPT in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Ending early registration due to low registration status and lack of research). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stent Comparison Study: target-lesion failure (TLF) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.

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SMART-CHOICE4 Clinical Trial NCT05066789 | AzTrials