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NCT number NCT03355742
Study type Interventional
Source Abbott Vascular
Contact Mariah Tackett
Phone 4088453000
Email MTackett@sjm.com
Status Not yet recruiting
Phase N/A
Start date December 27, 2017
Completion date January 2020

Clinical Trial Summary

XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS, XIENCE PROX EECSS, or XIENCE Sierra EECSS of coronary drug-eluting stents


Clinical Trial Description

The XIENCE 28 Global Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. Approximately 800 subjects from approximately 50 sites globally will be registered in this trial. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting and have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor and continue with aspirin monotherapy after 1-month follow-up.

All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 Global Study will be compared with the historical control of HBR subjects.


Study Design


Related Conditions & MeSH terms


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