IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome (OPTION2)

The OPTION2 trial (randomized controlled trial of IndObufen versus asPirin after coronary drug-eluting stent implantaTION in elderly patients with acute coronary syndrome) was designed to compare the 1-year clinical efficacy and safety of indobufen-based dual antiplatelet therapy (DAPT) (indobufen 100mg bid plus ticagrelor 90mg bid) or conventional DAPT (aspirin 100mg qd plus ticagrelor 90mg bid) in acute coronary syndrome (ACS) patients aged over 65 years old undergoing coronary drug-eluting stent (DES) implantation.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Antiplatelet Drugs
• Intervention / Treatment: Drug: Indobufen; Drug: Ticagrelor; Drug: Aspirin

• Study Type: Interventional
• Enrollment (Estimated): 2846
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lili Xu, Dr; Phone Number: 8615901823966; Email: lilixu1991@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • ZhongShan Hospital FuDan University
      • Contact: Lili Xu, MD; Phone Number: 8615901823966; Email: lilixu1991@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age over 65 years old
• Diagnosed with acute coronary syndrome (unstable angina/ non-ST elevation myocardial infarction/ ST elevation myocardial infarction)
• Treated with at least 1 DES implanted in the coronary lesion
• Receiving dual antiplatelet therapy (aspirin plus ticagrelor)
• Agree to attend the trial

Exclusion Criteria:

• Elective surgical procedure planned within 12 months
• Life expectancy ≤1 year
• Known allergy or intolerance to aspirin, ticagrelor or nonsteroidal anti-inflammatory drugs (NSAIDs)
• History of cerebral hemorrhage
• History of stroke in six months
• Active bleeding
• Known relevant hematological deviations
• Known, clinically important thrombocytopenia (i.e., <100*10^9/L) or anemia (i.e., <90g/L)
• Active cancer
• Concomitant use of oral anticoagulants
• Active participation in another clinical study
• Other situations in which the investigator considers unsuitable to attend the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: indobufen plus ticagrelor; Patients meeting the criteria are randomized before discharge from the hospital and given indobufen 100 mg bid and ticagrelor 90mg bid the second day after randomization. The administration shall last 12 months.	Drug: Indobufen; Patients meeting the criteria are randomized before discharge from the hospital and given indobufen 100mg bid and ticagrelor 90mg bid the second day after randomization. The administration shall last 12 months.; Drug: Ticagrelor; All the patients meeting the criteria and enrolled in the study are given ticagrelor 90mg bid for 12 months.
Active Comparator: aspirin plus ticagrelor; Patients meeting the criteria are randomized before discharge from the hospital and continued aspirin 100 mg qd and ticagrelor 90mg bid. The administration shall last 12 months.	Drug: Ticagrelor; All the patients meeting the criteria and enrolled in the study are given ticagrelor 90mg bid for 12 months.; Drug: Aspirin; Patients meeting the criteria are randomized before discharge from the hospital and continued aspirin 100 mg qd and ticagrelor 90mg bid. The administration shall last 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
net adverse clinical events (NACEs)	including ischemic and bleeding events, i.e., a composite of cardiovascular (CV) death, nonfatal myocardial infarction (MI), ischemic stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) criteria type 2, 3 or 5 bleeding	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a composite of CV death, nonfatal MI, ischemic stroke, definite or probable ST	ischemic events	1-year
BARC criteria type 2, 3 or 5 bleeding events	bleeding events	1-year
a composite endpoint of CV death, nonfatal MI, ischemic stroke, definite or probable ST, or BARC criteria type 3 or 5 bleeding	key composite endpoint	1-year
all-cause mortality	death from any cause	1-year

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 8, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Purines; Phenols; Benzene Derivatives; Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Adenosine; Purine Nucleosides; Ticagrelor; Aspirin; indobufen
• Other Study ID Numbers: B2024-187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No