NCT03815175

XIENCE 28 USA Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,605 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be registered from approximately 50 sites in the United States and Canada. Subject registration is capped at 75 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 continued 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 USA Study will be pooled with the data from the XIENCE 28 Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA Study.

Conditions

• Bleeding Disorder
• Ischemic Stroke
• Hemorrhagic Stroke
• Hematological Diseases
• 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 (aspirin and/or P2Y12 receptor inhibitor)	"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.

Timeline

• Start date: 2019-02-25
• Primary completion: 2020-08-14
• Completion: 2021-02-04
• First posted: 2019-01-24
• Last updated: 2022-05-03
• Results posted: 2021-12-14

Locations

111 sites across 15 countries: United States, Austria, Belgium, Canada, China, Germany, Hong Kong, Italy, Netherlands, Portugal, Singapore, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated device study