Clinical trial
ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
Name
C1114
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).
Trial arms
Trial start
2015-12-01
Estimated PCD
2018-12-08
Trial end
2023-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
1-month DAPT
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists
Arms:
1-month DAPT
12-month DAPT
12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists
Arms:
12-month DAPT
Size
3045
Primary endpoint
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding
12-month
Eligibility criteria
Inclusion Criteria:
* Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent
* Patients who are capable of oral dual antiplatelet therapy consisting of asprin 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 (Xience) implanted at the time of enrollment
* Patients comfirmed to have no tolerability to clopidgorel before enrollment
* Patients requiring continuous administration of antiplaelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
* Patients with coronary bioabsorbable vascular scaffolds (BVS) implanted prior to or at the time of enrollment
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3045, 'type': 'ACTUAL'}}
Updated at
2023-04-04
1 organization
2 products
1 indication
Organization
Kyoto University, Graduate School of MedicineProduct
1-month DAPTIndication
Coronary Artery DiseaseProduct
12-month DAPT