CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,605 enrolled
Drug / intervention
DAPT (aspirin and/or P2Y12 receptor inhibitor) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03815175
NCT03815175N/ACompleted
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XIENCE 28 USA Study

Abbott Medical Devices·interventional·Posted Jan 24, 2019·Updated May 3, 2022

In Brief

A clinical study evaluating XIENCE and DAPT (aspirin and/or P2Y12 receptor inhibitor) for Bleeding Disorder and 8 related conditions. Completed, enrolled 1,605 participants across 111 sites in 15 countries.

Detailed Summary

The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate 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 and XIENCE Sierra EECSS) of coronary drug-eluting stents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBleeding Disorder, Ischemic Stroke, Hemorrhagic Stroke, Hematological Diseases, Thrombocytopenia, Coagulation Disorder, Anemia, Renal Insufficiency, Coronary Artery Disease
CountriesAustria, Belgium, Canada, China, Germany, Hong Kong, Italy, Netherlands, Portugal, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 24, 2019
Enrollment StartFeb 25, 2019
Primary CompletionAug 14, 2020
Study CompletionFeb 4, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.4 years ago

Interventions

XIENCEdevice

Subjects who received XIENCE family stent systems will be included.

DAPT (aspirin and/or P2Y12 receptor inhibitor)drug

"1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.