Phase 4 Heart Disease Trial, Recruiting NCT05418556 Sponsor: Asan Medical Center Condition: Heart Disease
Back to Heart Disease

Phase 4 Heart Disease Trial, Recruiting

NCT05418556
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 19 years or older
  • People experiencing typical chest pain, or who have test results showing reduced blood flow to the heart, where a procedure to open blocked arteries (called PCI) is considered appropriate
  • People who have new blockages in their heart arteries that are suitable for treatment with a drug-coated stent
  • People whose stent was placed using a specialised imaging technique (either IVUS or OCT) during the procedure, and where the imaging confirmed the stent was well-positioned and met specific measurement standards (confirm exact technical details with trial site)
  • People who have read and signed a written consent form agreeing to take part and attend follow-up appointments, as approved by the relevant ethics committee

Who may not be able to join:

  • People whose blocked artery is located in a bypass graft
  • People whose artery blockage is in a location where the imaging equipment would be difficult to use — for example, where the artery has a very sharp bend, excessive twisting, or heavy calcium deposits near or within the blockage
  • People who have a previously treated artery where the stent has re-narrowed (in-stent restenosis)
  • People who have a known allergy or sensitivity to the materials in the stent device, including cobalt, chromium, nickel, platinum, tungsten, or certain polymers, that cannot be managed with prior medication
  • People with a persistently low platelet count (a type of blood cell important for clotting) below a certain level
  • People who have ever had a bleeding stroke or bleeding in the brain, or who have had a mini-stroke or ischemic stroke within the past 6 months
  • People with a known allergy or intolerance to aspirin, clopidogrel, ticagrelor, or heparin (blood-thinning medications used in this type of procedure)
  • People who need to take long-term blood-thinning tablets (oral anticoagulants) or a medication called cilostazol
  • People who have surgery planned within 12 months after the procedure that would require general anaesthesia or stopping blood-thinning medications
  • People who have been diagnosed with cancer (other than certain minor skin cancers) in the past 3 years, or who are currently being treated for cancer
  • People who have a significant abnormal finding on examination, blood tests, or heart tracing that the study doctor believes would make it unsafe to participate
  • People with a history of advanced liver disease (Child-Pugh B or C) or a blockage in the bile ducts
  • People whose life expectancy is less than 1 year for any reason
  • People who were in cardiogenic shock (a serious condition where the heart cannot pump enough blood) at the time of their hospital admission
  • People who are pregnant or breastfeeding
  • People who are actively bleeding or are considered to be at very high risk of serious bleeding (for example, due to active stomach ulcers, certain bowel conditions, or cancers with a high bleeding risk)
  • People who are unwilling or unable to follow the procedures required by the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 82 2-2045-3798

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
21 October 2022
Est. completion
31 December 2027

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]; 2) net clinical outcome defined as a composite of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding [BARC 2, 3, or 5]; 3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov