IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome
NCT ID: NCT06451198
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
2846 participants
INTERVENTIONAL
2024-07-01
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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indobufen plus 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.
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.
Ticagrelor
All the patients meeting the criteria and enrolled in the study are given ticagrelor 90mg bid for 12 months.
aspirin plus 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Junbo Ge
Professor
Central Contacts
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Other Identifiers
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B2024-187
Identifier Type: -
Identifier Source: org_study_id
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