NCT06763744Not yet recruitingPhase 4
Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients With ACS and HBR
SMart Angioplasty Research Team- Genotype-Guided Abbreviated DUal AntIplatelet Therapy Versus Un-Guided De-escalation Therapy in Patients With Acute Coronary SyndromE and High Bleeding Risk (SMART-GUIDE-HBR)
Source: ClinicalTrials.gov · Last updated 18 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this study is to assess the safety and efficacy of the CYP2C19 genotype-guided abbreviated dual antiplatelet therapy (DAPT) strategy versus the un-guided stepwise intensity de-escalation of DAPT strategy in patients with acute coronary syndrome (ACS) and high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 3000 (estimated)
- First submitted
- 1 Jan 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT06763744
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 3000
- From 1 Jun 2025 to the primary completion date, 31 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who need chronic anti-coagulation therapy.
- Patients with known intolerance to aspirin, all P2Y12 inhibitors, or components of drug-eluting stents.
Other illness
- Patients suffering from cardiogenic shock or cardiac arrest
- 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).
Lab values
- Clinically significant out of range values for platelet count (\< 50,000/mm3) or hemoglobin (\<8 g/dL) at screening
Other
- Patients unable to provide consent.
- Pregnant or lactating women.
Who the study is looking for
- Patients must be at least 19 years of age
- Patients who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
- Patients presenting with ACS (ST-elevation myocardial infarction \[STEMI\] or non-ST-elevation \[NSTE\] ACS).
- Patients with at least one lesion with equal or greater than 50% diameter stenosis requiring treatment with drug-eluting stents in native coronary artery or graft.
- Patients with high bleeding risk (by ARC-HBR definition or PRECISE-DAPT score 25 or more)
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.