Single vs. dual antiplatelet therapy after drug-coated balloon PCI in coronary disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label randomized study compares single antiplatelet therapy using a P2Y12 inhibitor to the standard dual antiplatelet therapy after successful PCI with a rapamycin drug-coated balloon (without stent implantation) in patients with chronic coronary syndrome or stable acute coronary syndrome. Eligible participants have small- to medium-sized vessels (2.0–4.5 mm) and limited treated segments, and have already achieved satisfactory post-procedure vessel patency. The trial focuses on ischemic and bleeding outcomes to determine non-inferiority of SAPT compared with DAPT in this specific PCI modality. Recruitment will involve leading centers in Beijing, Haikou, and Harbin.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Subjects who successfully underwent percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) treatment without stent implantation are eligible for inclusion in this study if Male and female patients who meet the following criteria：

1. Age ≥ 18 years.
2. target lesion in vessels with diameter ≥2.0 and ≤4.5 mm (visual estimation).
3. the total target vessels ≤2 and a total of target lesions ≤2.
4. Total length of DCB used for target lesions \<60 mm.
5. The subject's indication for PCI is chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS), include Silent Ischemia, stable angina (SA), unstable angina (UA), non-ST-segment elevation myocardial (NSTEMI), or ST-segment elevation acute myocardial infarction (STEMI) with onset \>2 weeks.
6. All lesions were successfully treated with a drug-eluting balloon during routine clinical practice, i.e., post-procedural angiographic visual diameter stenosis \<30%.
7. At the operator's discretion, no flow-limiting angiographic complications requiring extension of dual antiplatelet therapy (DAPT)have occurred.
8. All PCI stages have been completed (if applicable), and no further PCI procedures are planned.

Inclusion criteria at the randomization visit within 24 hours post-index PCI:

At the time of the randomization visit (within 24 hours after successful drug-eluting balloon treatment during index PCI), the following criteria mustbe met:

The subject must have had an uneventful clinical course within 24 hours post-index PCI, i.e., no myocardial infarction,symptomatic restenosis, device-related thrombus formation, stroke, or any revascularization procedure (coronary or non-coronary)requiring extension of dual antiplatelet therapy.

Exclusion Criteria:

Patients will be ineligible if they meet any of the following criteria:

1. Stent implantation within 6 months prior to index percutaneous coronary intervention (PCI).
2. Treatment for in-stent thrombosis (IST) at the time of index PCI or within 6 months prior to it.
3. Treatment with a bioabsorbable stent at any time prior to index PCI.
4. Acute myocardial infarction with ST-segment elevation within the past two weeks.
5. True bifurcation lesions requiring treatment with two stents (Medina 1,1,1/1,0,1/0,1,1) with a branch vessel diameter≥2.5 mm (visual estimation).
6. Chronic total occlusion of the target lesion (≥3 months).
7. Unprotected left main coronary artery.
8. Thrombus present in the target lesion (imaging/visual).
9. Total length of DCB used in the target lesion ≥60 mm.
10. Active bleeding requiring medical intervention (BARC ≥2) at the time of randomization.
11. Indications for long-term oral anticoagulation therapy.
12. Life expectancy of less than 1 year.
13. Known allergy or hypersensitivity to aspirin, clopidogrel, ticagrelor, or sirolimus.
14. Currently participating in another trial and has not yet reached the primary endpoint.
15. History of asthma induced by salicylates or substances with similar effects (particularly nonsteroidal anti-inflammatory drugs).
16. Pregnant or breastfeeding women.
17. Inability to understand and follow study-related instructions or to comply with the study protocol.
18. Inability to provide written informed consent

Where it's running

• Affiliated Hospital of Jining Medical University
  Jining, Shandong, China Recruiting
• Beijing Luhe Hospital Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• The First Affiliated Hospital of Hainan Medical University
  Haikou, Hainan, China Not yet recruiting
• The 2nd Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Not yet recruiting
• The Second Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Not yet recruiting
• Heze Municipal Hospital
  Heze, Shandong, China Not yet recruiting

Study contacts

• Study coordinator: Yong Cao
• Email: caoyong0419@163.com
• Phone: +86-0537-2905210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.