Clinical trial
Study to Evaluate the Safety of Reducing Dual Antiplatelet Therapy (DAPT) Duration to 1 Month for Patients With Acute Coronary Syndrome (ACS) After Implantation of Everolimus-eluting Cobalt-chromium Stent
Name
C1348
Description
The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES) under the setting of acute coronary syndrome (ACS).
Trial arms
Trial start
2018-04-02
Estimated PCD
2021-12-31
Trial end
2026-03-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
1-months DAPT
1-month DAPT followed by 59-month monotherapy
Arms:
1-month DAPT
12-month DAPT
12-month DAPT followed by 48-month monotherapy
Arms:
12-month DAPT
Size
3008
Primary endpoint
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
12 months
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
60 months
Eligibility criteria
Inclusion Criteria:
* Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent under the setting of acute coronary syndrome
* Patients who are capable of oral dual antiplatelet therapy consisting of aspirin and P2Y12 receptor antagonist
Exclusion Criteria:
* Patients requiring oral anticoagulants
* Patients with medical history of intracranial hemorrhage
* Patients who have experienced serious complications (myocardial infarction, stroke, and major bleeding) during hospital stay after percutaneous coronary intervention
* Patients with drug eluting stents other than Cobalt chromium everolimus eluting stents implanted at the time of enrollment
* Patients confirmed to have no tolerability to clopidogrel before enrollment
* Patients requiring continuous administration of antiplatelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3008, 'type': 'ACTUAL'}}
Updated at
2023-04-04
1 organization
2 products
5 indications
Organization
Kyoto University, Graduate School of MedicineProduct
1-months DAPTIndication
Acute Coronary SyndromeIndication
Myocardial InfarctionIndication
Coronary Artery DiseaseIndication
AngioplastyIndication
Antiplatelet agentsProduct
12-month DAPT