Last updated on December 2018

XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.


Brief description of study

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.

Detailed Study Description

  1. 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.

Clinical Study Identifier: NCT03218787

Contact Investigators or Research Sites near you

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St. John's Hospital

Springfield, IL United States
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Heart Center Research LLC

Huntsville, AL United States
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Scottsdale Healthcare

Scottsdale, AZ United States
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Arkansas Heart Hospital

Little Rock, AR United States
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John Muir Health Concord

Concord, CA United States
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Washington Hospital

Fremont, CA United States
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Scripps Memorial Hospital

La Jolla, CA United States
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Cedars-Sinai Medical Center

Los Angeles, CA United States
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St. Vincent's Medical Center

Los Angeles, CA United States
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Sharp Grossmont Hospital

San Diego, CA United States
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Sharp Memorial Hospital

San Diego, CA United States
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JFK Medical Center

Atlantis, FL United States
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Morton Plant Hospital

Clearwater, FL United States
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North Florida Regional

Gainesville, FL United States
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Tallahassee Memorial Hospital

Tallahassee, FL United States
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Augusta Medical Center

Augusta, GA United States
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Elkhart General Hospital

Elkhart, IN United States
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The St. Vincents Heart Center

Indianapolis, IN United States
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Genesis Medical Center

Davenport, IA United States
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Kansas Heart Hospital

Wichita, KS United States
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Baptist Health Louisville

Louisville, KY United States
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Lahey Clinic

Burlington, MA United States
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Baystate Medical Center

Springfield, MA United States
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McLaren Flint

Flint, MI United States
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Genesys Regional Medical Center

Grand Blanc, MI United States
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McLaren Greater Lansing

Lansing, MI United States
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Munson Medical Center

Traverse City, MI United States
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Abbott Northwestern Hospital

Minneapolis, MN United States
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CentraCare

Saint Cloud, MN United States
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St. Dominic Hospital

Jackson, MS United States
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St. Patrick Hospital

Missoula, MT United States
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Morristown Memorial Hospital

Morristown, NJ United States
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NewYork-Presbyterian/Queens

Flushing, NY United States
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Mount Sinai Medical Center

New York, NY United States
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St Francis Hospital

Roslyn, NY United States
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Presbyterian Heart Group

Charlotte, NC United States
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Wake Forest Baptist Medical Center

Winston-Salem, NC United States
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Integris Baptist Medical Center

Oklahoma City, OK United States
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Oklahoma Heart Institute

Tulsa, OK United States
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Holy Spirit Hospital

Camp Hill, PA United States
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Doylestown Hospital

Doylestown, PA United States
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UPMC Hamot

Erie, PA United States
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St. Mary Medical Center

Langhorne, PA United States
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Penn Presbyterian Medical Center

Philadelphia, PA United States
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Allegheny General Hospital

Pittsburgh, PA United States
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St. Joseph Medical Center

Wyomissing, PA United States
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Rhode Island Hospital

Providence, RI United States
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Anmed Health Medical Center

Anderson, SC United States
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Greenville Health System

Greenville, SC United States
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Sanford Health

Sioux Falls, SD United States
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Erlanger Medical Center

Chattanooga, TN United States
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Baptist Memorial Hospital

Germantown, TN United States
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Turkey Creek Medical Center

Knoxville, TN United States
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Centennial Medical Center

Nashville, TN United States
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Heart Hospital of Austin

Austin, TX United States
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Inova Fairfax Hospital

Falls Church, VA United States
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Mary Washington Hospital

Fredericksburg, VA United States
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Recruitment Status: Open


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