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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06451198
Other study ID # B2024-187
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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