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Heart stent showdown: does adding a procedure to pills prevent more heart attacks?

NCT ID NCT07577518

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will compare two approaches for people with chronic coronary syndrome (narrowed heart arteries): getting a stent plus standard medications versus medications alone. About 2,301 participants will be randomly assigned to one group, and researchers will track major heart events like heart attacks or death. A smaller substudy will also test two forms of the drug carvedilol for angina control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
percutaneous coronary intervention (PCI) and carvedilol
What this could lead to
If successful, this could show that adding a stent procedure to standard medications reduces major heart events like heart attacks or death in people with chronic coronary syndrome.
What could go wrong
This trial hasn't started yet, and results may not show a clear benefit of PCI over medication alone. The carvedilol substudy is small (220 people), so findings may be limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,301 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Mar 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged 40 years or older * Patients suspected of having chronic coronary syndrome who have undergone coronary angiography and confirmed stenotic lesions * Patients with lesions suitable for stent insertion who have 50% or more visually estimated stenosis in major coronary arteries with a diameter of 2.5 mm or greater observed on coronary angiography, and who satisfy one or more of the following conditions: 1. Patients with stenosis of 70% or more confirmed via Quantitative coronary angiography (50% or more for the left main coronary artery) 2. Minimum lumen area (MLA) ≤ 4 mm² or plaque burden \>70% on intravascular ultrasound (IVUS) 3. MLA \<3.5 mm² or area stenosis (AS) \>65% on Optical Coherence Tomography (OCT) 4. The corresponding stenosis on localizing stress imaging using SPECT or PET When there is a significant focal ischemic deficit in the coronary artery region of the lesion and the total perfusion deficit (TPD) is ≥10% 5. Pressure wire-based fractional flow reserve (FFR) ≤0.80 * Patients who can verbally confirm their understanding of invasive physiological or imaging evaluations and the benefits, harms, and alternative treatments of coronary angioplasty using drug-eluting stents, and for whom the patient or their legal representative can submit a written consent form. Additional Criteria for nested RCT Studies * When heart rate control is deemed therapeutically important due to an accompanying increase in heart rate at rest or during symptomatic episodes. * When the use of beta-blockers is deemed clinically advantageous due to a history of myocardial infarction. * When beta-blockers can help control blood pressure and symptoms in cases of concomitant hypertension. * When there is a clinical situation requiring associated tachyarrhythmia or heart rate control. * When beta-blockers are deemed more appropriate due to a history of contraindications, intolerance, or side effects of calcium channel blockers. Exclusion Criteria: * Patients with Left Ventricular Ejection Fraction (LVEF) less than 35% * Patients with cardiogenic shock * Patients with pulmonary edema or heart failure unresponsive to standard treatment * Patients with unstable angina whose symptoms persist despite maximal drug therapy * Patients with a history of ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina within the last 6 months * Patients with active bleeding * Patients with major bleeding of the gastrointestinal or urinary system within the last 3 months * Patients with coagulation disorders prone to bleeding (including heparin-induced thrombocytopenia) * Patients with hypersensitivity to or contraindications to the following drugs: Heparin, Aspirin, Clopidogrel, Prasugrel, Contrast media (Patients sensitive to contrast media are not excluded if the condition can be effectively prevented through pretreatment with steroids or diphenhydramine (e.g., flare-ups). * Patients for whom percutaneous coronary intervention (PCI) is contraindicated * Patients who have already undergone coronary artery bypass grafting (CABG) * Patients with in-stent restenosis in the target lesion * Patients with chronic total occlusion (CTO) in major coronary arteries * Patients with lesions having an FFR of less than 0.64 * Patients with coronary arteries that are anatomically unsuitable for both PCI and CABG * Patients with non-ischemic dilated cardiomyopathy or hypertrophic cardiomyopathy * Patients with severe valvular disease or those judged by the investigator to be likely to require valve surgery or percutaneous valve replacement during the study period * Patients with non-cardiac diseases, etc., with a life expectancy of less than one year or expected to have low treatment adherence (at the investigator's judgment) * Pregnant or breastfeeding patients * Other patients deemed by the investigator to be unsuitable for participation in the clinical trial Additional Criteria for nested RCT Studies * Significant bradycardia at rest, second-degree or higher atrioventricular block, or significant conduction disturbance * Bronchial asthma or clinically significant bronchospasmodic disease * Symptomatic hypotension * Variant angina as a main presentation * Other cases where the supervising investigator deems the use of beta-blockers medically inappropriate

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bucheon Sejong Hospital

    Bucheon-si, Gyeonggi-do, 14754, South Korea

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • Chungnam National University Hospital

    Gwangju, 61469, South Korea

  • Ewha Womans University Medical Center

    Seoul, 07804, South Korea

  • GangNeung Asan Hospital

    Gangneung, Gangwon-do, 25440, South Korea

  • Hallym University Medical Center

    Anyang-si, Gyeonggi-do, 14068, South Korea

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggi-do, 10380, South Korea

  • Jeju National University Hospital

    Jeju City, 63241, South Korea

  • Kangdong Sacred Heart Hospital

    Seoul, 05355, South Korea

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do, 24289, South Korea

  • Keimyung University Dongsan Hospital

    Daegu, 41931, South Korea

  • Koera University Guro Hospital

    Seoul, 08308, South Korea

  • Kosin University Gospel Hospital

    Busan, 49267, South Korea

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Samsung Changwon Medical Center

    Changwon, Gyeongsangnam-do, 51353, South Korea

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061, South Korea

  • The Catholic University of Korea Daejeon St. Mary's Hospital

    Daejeon, 34943, South Korea

  • Ulsan Univeristy Hospital

    Ulsan, 44033, South Korea

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