A randomized controlled trial of ind0bufen versus asPirin aftercoronary drug-eluting stentimplantaTION: The OPTION trial

Conditions

Coronary atherosclerotic heart disease

Lili Xu, Huajie Xu, Shujing Wu, Huanyi Zhang, Kang Cheng et al. (16 authors)

American Heart Journal2024-12-203 citations

10.1016/j.ahj.2024.12.007

Indobufen or Aspirin on Top of Clopidogrel After Coronary Drug-Eluting Stent Implantation (OPTION): A Randomized, Open-Label, End Point–Blinded, Noninferiority Trial

Hongyi Wu, Lili Xu, Xin Zhao, Huanyi Zhang, Kang Cheng et al. (16 authors)

Circulation2022-11-0648 citations

10.1161/circulationaha.122.062762

Interventions

Indobufen +Clopidogrel:Indobufen: 100mg/bid +Clopidogrel: 75mg/qd

Aspirin+Clopidogrel:Aspirin: 75mg/qd+Clopidogrel: 75mg/qd

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-75 years; (2) hospitalized due to subjective or objective myocardial ischemia; (3) troponin (TNT or TNI) negative; (4) successfully placed at least one drug stent and agreed to return to hospital.

Exclusion criteria

Exclusion criteria: (1) Serious complications in PCI; (2) Require CABG treatment; (3) The admission prompt TNT or TNI increased; (4) Acute myocardial infarction occurred within 1 year before admission; (5) It is expected that surgery to stop the use of anti-platelet drugs within one year; surgery for the use of platelet drugs; (6) Life expectancy is less than 1 year; (7) known to aspirin, clopidogrel and non-steroidal anti-inflammatory drugs can not tolerate or allergies; (8) history of previous cerebral hemorrhage; (9) Stroke occurred within six months; (10) active bleeding; (11) Hemorrhagic disease is known; (12) Known malignant disease; (13) Severe hepatic and renal insufficiency (ALT >= 1.5 ULN, AST >= 1.5 ULN and Cr > 1.5 ULN); (14) active peptic ulcer; (15) at the same time need oral anticoagulant drugs; (16) Platelets below 100 x 10^9/L; (17) hemoglobin less than 90g/L; (18) Pregnancy or breastfeeding; (19) patients who participated in other interventional clinical studies; (20) Patients considered unsuitable for inclusion in this study by researchers.

Design outcomes

Primary

Measure	Time frame
Cardiac death;Non-fatal myocardial infarction;Ischemic stroke;Possible or confirmed clinical composite endpoint of stent thrombosis or BARC hemorrhage (type 2, type 3 or type 5);	—

Secondary

Measure	Time frame
Cardiac deaths at 1 month, 3 months, 6 months and 12 months, non-fatal myocardial infarction, ischemic stroke or stent thrombosis;BARC bleeding at 1 month, 3 months, 6 months and 12 months;Cardiac deaths at 1 month, 3 months, 6 months, and 12 months, non-fatal myocardial infarction, stroke, possible or definite stent thrombosis or BARC bleeding;	—

Countries

China

Contacts

Public ContactJunbo Ge

Zhongshan Hospital affiliated to Fudan University

ge.junbo@zs-hospital.sh.cn+86 021-64041990

Outcome results

None listed