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

ConditionsCoronary Artery DiseaseAntiplatelet Drugs
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

2,846 Participants
are divided into 2 treatment groups
Group A: indobufen plus ticagrelorExperimental treatment 2 interventions
Group B: aspirin plus ticagrelorActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
1-year

Secondary outcomes

1

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

ischemic events

Time frame
1-year
2

BARC criteria type 2, 3 or 5 bleeding events

bleeding events

Time frame
1-year
3

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

Time frame
1-year
4

all-cause mortality

death from any cause

Time frame
1-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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