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

Coronary Artery Disease Clinical Trial

— OPTION2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451198
• Other study ID #: B2024-187
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: June 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Lili Xu, Dr
• Phone: 8615901823966
• Email: lilixu1991[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2846
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	a composite of CV death, nonfatal MI, ischemic stroke, definite or probable ST	ischemic events	1-year
Secondary	BARC criteria type 2, 3 or 5 bleeding events	bleeding events	1-year
Secondary	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
Secondary	all-cause mortality	death from any cause	1-year