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A randomized comparison of CLOpidogrel monotherapy versus extended dual-antiplatelet therapy beyond 12 months after implantation of drug-eluting StEnts in high-risk lesions or patients; A-CLOSE trial

A randomized comparison of CLOpidogrel monotherapy versus extended dual-antiplatelet therapy beyond 12 months after implantation of drug-eluting StEnts in high-risk lesions or patients; A-CLOSE trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0003911
Enrollment
3200
Registered
2019-05-14
Start date
2019-08-14
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patietns who were stable for 12 months after DES implantation in spite of high risk of ischemic and bleedig events would be included in this study and randomly assigned 1:1 to the experimental

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria (must all met) 1. Patients >19 years old 2. Patients who underwent DES implantation 12 months (±5 months) previously. 3. High risk characteristics (clinical or lesion) for ischemic events (must at least one) High risk patients; clinical criteria (1) Acute coronary syndrome (2) Previous history of cerebrovascular accidents (3) History of peripheral artery intervention (4) Heart failure (left ventricular ejection fraction =40%) (5) Diabetes treated with medication (6) Chronic renal insufficiency including end-stage renal diseases High risk lesions; angiographic or procedural criteria (1) Left main diseases (2) Bifurcation lesions (3) Chronic total occlusion (4) In-stent restenotic lesions (5) Graft lesions (6) Diffuse long lesions requiring total stent length =28 mm (7) Calcified lesions requiring atherectomy (8) Multivessel coronary artery disease with multiple stents (9) Small vessel disease requiring stent diameter of =2.5 mm

Exclusion criteria

Exclusion criteria: 1. Age> 80 years 2. Pregnant women or women with potential childbearing 3. Life expectancy < 1 year 4. Refusal or inability to understand of informed consent

Design outcomes

Primary

MeasureTime frame
Net clinical adverse event [NACE]

Secondary

MeasureTime frame
Each components of NACE;All-cause or cardiovascular mortality;Major or minor bleeding;Major adverse cardiac event;Major Adverse Cardiac and Cerebrovascular Event

Countries

Korea, Republic of

Contacts

Public ContactSung-Jin Hong

Yonsei University Health System, Severance Hospital

hongs@yuhs.ac+82-2-2228-8452

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026