NCT04418479CompletedPhase 4
SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3
Clopidogrel Versus Aspirin Monotherapy After Percutaneous Coronary Intervention and Standard Dual Antiplatelet Therapy in Patients At High Risk for Recurrent Ischemic Events
Source: ClinicalTrials.gov · Last updated 30 Jan 2025
Brief summary (registry, in English)
This study is a prospective, open-label, two-arm, randomized multicenter trial to compare the efficacy and safety of clopidogrel versus aspirin monotherapy beyond the standard duration of dual antiplatelet therapy (DAPT) (more than 12 months for myocardial infarction \[MI\] and more than 6 months for non-MI) after percutaneous coronary intervention (PCI) in patients at high risk of recurrent ischemic events.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 5506 (actual)
- First submitted
- 1 Jun 2020
- Start date
- 10 Aug 2020
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Joo-Yong Hahn
- Diseases
- Coronary artery disease
- NCT number
- NCT04418479
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 5506
- From 10 Aug 2020 to the primary completion date, 31 Oct 2024
- 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 continuous anticoagulant therapy.
- A patient who are taking single antiplatelet therapy at screening
Other illness
- Known hypersensitivity or contraindications to study medications (aspirin or clopidogrel)
- Patients who require DAPT due to atherosclerotic disease other than coronary artery disease
- Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
Other
- Patients who are scheduled for revascularization treatment of coronary artery
- Pregnant or lactating women
Who the study is looking for
- Subject must be at least 19 years of age
- Patients at high risk of recurrence of ischemic events who have undergone PCI using a DES and are receiving standard DAPT (12 months\* or more for myocardial infarction and 6 months\* or more for non-myocardial infarction)
- Patients at high risk for recurrent ischemic events, which were defined as one or more of the following clinical or lesion characteristics.
- Clinical characteristics
- Patients with prior myocardial infarction.
- Patients with diabetes mellitus who receive oral hypoglycemic agent or insulin.
- Complex lesion characteristics Complex lesion was defined as one or more of the following.
- True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) and is able to assess the side branch ostium
- Chronic total occlusion (≥3 months) as target lesion
- PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions)
- Long coronary lesions (implanted stent length ≥38 mm)
- Multi-vessel PCI (≥ 2 vessels treated at one PCI session)
- Multiple stent needed (≥ 3 stents per patient)
- In-stent restenosis lesion as target lesion
- Severely calcified lesion (encircling calcium in angiography) i . Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
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.