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Clinical Trial Summary

The investigators hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation.


Clinical Trial Description

Patients at high risk for either ischemic or bleeding complications, but who were stable without clinical events for 12 months after DES implantation will be included in this study. Eligible patients will be randomized to continue DAPT (aspirin plus clopidogrel) for further 24 months or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone). Randomization will be stratified according to 1) clinical presentation (acute coronary syndrome or stable coronary artery disease) and 2) age (≥75 or <75). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative. All of study subjects will be have an outpatient visit as scheduled in outpatient clinic. Occurrence of study endpoints will be documented at clinical visit or telephone interview every 6 months since randomization. Antiplatelet drugs will be open-label and prescribed by attending physician. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03947229
Study type Interventional
Source Yonsei University
Contact
Status Not yet recruiting
Phase Phase 4
Start date June 2019
Completion date April 2023

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