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NCT Number: NCT06451198

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

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.

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Key information

Conditions

Coronary Artery Disease Antiplatelet Drugs Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Lili Xu, MD

CONTACT

[email protected]

8615901823966

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indobufen

Drug

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.

Aspirin

Drug

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.

Ticagrelor

Drug

All the patients meeting the criteria and enrolled in the study are given ticagrelor 90mg bid for 12 months.

Primary outcomes

  1. net adverse clinical events (NACEs)

    Time frame: 1-year

    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

Secondary outcomes

  1. a composite of CV death, nonfatal MI, ischemic stroke, definite or probable ST

    Time frame: 1-year

    ischemic events

  2. BARC criteria type 2, 3 or 5 bleeding events

    Time frame: 1-year

    bleeding events

  3. a composite endpoint of CV death, nonfatal MI, ischemic stroke, definite or probable ST, or BARC criteria type 3 or 5 bleeding

    Time frame: 1-year

    key composite endpoint

  4. all-cause mortality

    Time frame: 1-year

    death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Lili Xu, Dr

CONTACT

[email protected]

8615901823966

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Acronym: OPTION2

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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