NCT03355742

XIENCE 28 Global Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 963 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, XIENCE ProA EECSS or XIENCE Sierra EECSS of coronary drug-eluting stents

Detailed description

The XIENCE 28 Global Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 800 to a maximum of 960 subjects will be registered from approximately 50 sites globally and subject registration is capped at 120 per site. 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 as early as 28 days and continue with aspirin monotherapy through 12-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 non-complex HBR subjects treated with standard DAPT up to 12 months from the XIENCE V USA Study .

Conditions

• Bleeding Disorder
• Stroke, Ischemic
• Stroke Hemorrhagic
• Hematological Disease
• Thrombocytopenia
• Coagulation Disorder
• Anemia
• Renal Insufficiency
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	XIENCE	Subjects who received XIENCE family stent systems will be included.
DRUG	DAPT	1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Timeline

• Start date: 2018-02-09
• Primary completion: 2019-10-24
• Completion: 2020-04-30
• First posted: 2017-11-28
• Last updated: 2021-03-04
• Results posted: 2021-02-08

Locations

52 sites across 13 countries: Austria, Belgium, China, Germany, Hong Kong, Italy, Netherlands, Portugal, Singapore, Spain, Switzerland, Taiwan, United Kingdom