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

Phase 4

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Drug: Aspirin; Drug: Indobufen; Drug: Ticagrelor

• Registration Number: NCT06451198
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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 70 years old undergoing coronary drug-eluting stent (DES) implantation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-08
• Study First Posted: 2024-06-11
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Study Start: 2024-07-01
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2846

Inclusion Criteria

• Age over 70 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
indobufen plus ticagrelor	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.
aspirin plus ticagrelor	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.
indobufen plus ticagrelor	Indobufen	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.
aspirin plus ticagrelor	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.

Primary Outcome Measures

Name	Time	Method
net adverse clinical events (NACEs)	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 Outcome Measures

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