XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.
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|ClinicalTrials.gov Identifier: NCT03218787|
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : December 6, 2018
XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family of coronary drug-eluting stents.
The XIENCE family stent systems include commercially approved XIENCE Xpedition Everolimus Eluting Coronary Stent System (EECSS), XIENCE Alpine EECSS, XIENCE PRO^X EECSS [rebrand of the XIENCE Xpedition Stent System and is only available outside of the United States (OUS)], XIENCE PRO^A EECSS (rebrand of the XIENCE Alpine Stent System and is only available OUS) and XIENCE Sierra EECSS of coronary drug-eluting stents.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Lesions||Device: XIENCE Drug: DAPT||Not Applicable|
A. Primary Objective:
To show non-inferiority of the primary endpoint of all death or all MI (modified ARC) from 3 to 12 months following XIENCE implantation in HBR subjects with HBR treated with 3-month DAPT compared to a historical control after propensity score adjustment.
B. Secondary Objective:
- To show superiority of the major secondary endpoint of major bleeding (Bleeding Academic Research Consortium [BARC] type 2-5) from 3 to 12 months following XIENCE implantation in HBR subjects treated with 3-month DAPT compared to a historical control after propensity score adjustment.
- To evaluate stent thrombosis (ARC definite/probable) from 3 to 12 months following XIENCE implantation in HBR subjects treated with 3-month DAPT against a performance goal (PG).
Approximately 2,000 subjects from approximately 100 sites globally will be enrolled, with at least 50% of subjects in the United States (US) and subject registration was capped at 300 per site.
All registered subjects will be followed at 3, 6 and 12 months post index procedure.
The data collected from this study will be compared 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, which is a US post-approval study to evaluate the safety of XIENCE V EECSS in "all-comer" population under real-world setting.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety Evaluation of 3-month Dual Antiplatelet Therapy in Subjects at High Risk of Bleeding Undergoing Percutaneous Coronary Intervention With XIENCE.|
|Actual Study Start Date :||June 15, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
|Experimental: XIENCE + 3-month DAPT||
Subjects who received XIENCE family stent systems will be included.
3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.
Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.
Other Name: Dual antiplatelet therapy
- Composite Rate of all Death or all Myocardial Infarction (MI)(modified Academic Research Consortium [ARC]) [ Time Frame: From 3 to 12 months ]
- Major bleeding rate (BARC type 2-5) [ Time Frame: From 3 to 12 months ]
- Stent thrombosis (ARC definite/probable) [ Time Frame: From 3 to 12 months ]
- All death, cardiac death, vascular death, non-cardiovascular death [ Time Frame: From 3 to 12 months ]
- All myocardial infarction (MI) and MI attributed to target vessel (TV-MI, modified ARC) [ Time Frame: From 3 to 12 months ]
- Composite of cardiac death or MI (modified ARC) [ Time Frame: From 3 to 12 months ]
- All stroke, ischemic stroke and hemorrhagic stroke [ Time Frame: From 3 to 12 months ]
- Clinically-indicated target lesion revascularization (CI-TLR) [ Time Frame: From 3 to 12 months ]
- Clinically-indicated target vessel revascularization (CI-TVR) [ Time Frame: From 3 to 12 months ]
- Target lesion failure (TLF, composite of cardiac death, TV-MI and CI-TLR) [ Time Frame: From 3 to 12 months ]
- Target vessel failure (TVF, composite of cardiac death, TV-MI and CI-TVR) [ Time Frame: From 3 to 12 months ]
- Major bleeding defined by the Bleeding Academic Research Consortium (BARC) type 3-5 [ Time Frame: From 3 to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218787
|Contact: Kunal Sampat||408 845 email@example.com|
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|Principal Investigator:||Roxana Mehran||Abbott Medical Devices|