Last updated on October 2017

EVOLVE Short DAPT Study


Brief description of study

The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.

Detailed Study Description

The primary objective of the EVOLVE Short DAPT Study is to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Stent System. The study will be conducted up to 120 sites worldwide in the United States, Europe, Japan, and Brazil with planned enrollment of up to 2,250 subjects. Clinical follow-up will be required at the following time points: 3 months, 6 months, 12 months and 15 months post index procedure. Subjects must be treated with one of the following P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor) for 3 months following the index procedure. Subjects must be treated with aspirin for the duration of the trial. The minimum daily maintenance dose of aspirin should be 75-100 mg. Subjects are eligible for discontinuation of P2Y12 inhibitor at 3 months if they meet both of the following criteria: subject was treated with 3 months of study required antiplatelet therapy post index procedure; and subject was free from events (stroke, MI, PCI, coronary artery bypass graft [CABG], and stent thrombosis) between the index procedure and the 3 month visit. Subjects are not eligible for discontinuation of P2Y12 inhibitor at 3 months if any of the following criteria are met: subject who experiences a stroke, MI, PCI, CABG and/or stent thrombosis, during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject who is non-compliant with study required antiplatelet therapy during the 0-3 month period (between the date of the index procedure and the date of the 3-month follow-up visit); or subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months due to another condition requiring chronic P2Y12 inhibitor use. All enrolled subjects who receive a SYNERGY stent must be followed at all milestones through 15-months, regardless of eligibility to discontinue P2Y12 inhibitor. Following the 3-month milestone, subjects who experience MI or stent thrombosis events should be treated per the investigator's discretion and should be followed through the 15-month visit.

Clinical Study Identifier: NCT02605447

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Akil Loli, MD

Banner Good Samaritan Regional Medical Center
Phoenix, AZ United States
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Hursh Naik, MD

St. Joseph's Hospital & Medical Center
Phoenix, AZ United States
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Scott Davis, MD

Baptist Health Medical Center (Little Rock)
Little Rock, AR United States
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David Mego, MD

Arkansas Heart Hospital
Little Rock, AR United States
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Tommy Lee, MD

Bakersfield Memorial Hospital
Bakersfield, CA United States
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Ray Matthews, MD

USC Medical Center
Los Angeles, CA United States
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Suhail Dohad, MD

Cedars - Sinai Medical Center
Los Angeles, CA United States
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Chidambaram Rammohan, MD

El Camino Hospital
Mountain View, CA United States
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Syed Bokhari, MD

HCA Riverside Community Hospital
Riverside, CA United States
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Pei-Hsiu Huang, MD

Sutter Medical Center, Sacramento
Sacramento, CA United States
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Reginald Low, MD

University of California, Davis Medical Center
Sacramento, CA United States
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Robert Lundstrom, MD

Kaiser Foundation Hospital - San Francisco
San Francisco, CA United States
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Quang Bui, MD

Harbor UCLA Medical Center
Torrance, CA United States
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Gary Gershony, MD

John Muir Medical Center
Walnut Creek, CA United States
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Lee MacDonald, MD

South Denver Cardiology Associates, PC
Littleton, CO United States
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Robert Attaran, MD

Yale-New Haven Hospital
New Haven, CT United States
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Ron Waksman, MD

Washington Hospital Center
Washington, D.C., United States
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Mark Rothenberg, MD

JFK Medical Center
Atlantis, FL United States
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Bernardo Stein, MD

Morton Plant Mease Healthcare System
Clearwater, FL United States
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Daniel VanRoy, MD

North Florida Regional Medical Center
Gainesville, FL United States
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Jonathan Roberts, MD

Memorial Regional Hospital
Hollywood, FL United States
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Robert Feldman, MD

Mediquest Research at Munroe Regional Medical Center
Ocala, FL United States
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Rohit Bhatheja, MD

Florida Hospital
Orlando, FL United States
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Thomas Shimshak, MD

Florida Hospital Heartland Medical Center
Sebring, FL United States
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Wayne Batchelor, MD

Tallahassee Memorial Hospital
Tallahassee, FL United States
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Patrick Hall, MD

University Hospital
Augusta, GA United States
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Mark Dorogy, MD

Medical Center of Central Georgia
Macon, GA United States
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Amar Patel, MD

Wellstar Kennestone Hospital
Marietta, GA United States
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Ronald Jenkins, MD

Kootenai Medical Center
Coeur d'Alene, ID United States
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Mark Ricciardi, MD

Northwestern Memorial Hospital
Chicago, IL United States
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Mark Goodwin, MD

Edward Hospital
Naperville, IL United States
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Nilesh Goswami, MD

St. John's Hospital
Springfield, IL United States
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Naveed Adoni, MD

Carle Foundation Hospital
Urbana, IL United States
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Saeed Shaikh, MD

Franciscan St. Francis Hospital
Beech Grove, IN United States
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Mark Meier, MD

Northern Indiana Research Alliance - Lutheran Hospital
Fort Wayne, IN United States
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Sandeep Dube, MD

Community Heart and Vascular Hospital
Indianapolis, IN United States
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Magdi Ghali, MD

Mercy Hospital Medical Center
Des Moines, IA United States
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Naresh Solankhi, MD

Jewish Hospital and St. Mary's Healthcare
Louisville, KY United States
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James Smith, MD

Cardiovascular Research, LLC
Shreveport, LA United States
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Samip Vasaiwala, MD

Maine Medical Center
Portland, ME United States
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John Wang, MD

Union Memorial Hospital
Baltimore, MD United States
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Carey Kimmelstiel, MD

Tufts Medical Center
Boston, MA United States
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Laura Mauri, MD

Brigham and Women's Hospital
Boston, MA United States
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Duane Pinto, MD

Beth Israel Deaconess Medical Center
Boston, MA United States
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Khaldoon Alaswad, MD

Henry Ford Hospital
Detroit, MI United States
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Wilson Ginete, MD

St. Mary's Duluth Clinic Regional Heart Center
Duluth, MN United States
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Ivan Chavez, MD

Abbott Northwestern Hospital
Minneapolis, MN United States
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Mudassar Ahmed, MD

HealthEast St. Joseph's Hospital
Saint Paul, MN United States
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Steven Laster, MD

St. Luke's Hospital of Kansas City
Kansas City, MO United States
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Jasvindar Singh, MD

Washington University School of Medicine
Saint Louis, MO United States
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Steven Rowe, MD

Cox Medical Centers
Springfield, MO United States
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James DeVries, MD

Dartmouth Hitchcock Medical Center
Lebanon, NH United States
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Richard Kovach, MD

Deborah Heart and Lung Center
Browns Mills, NJ United States
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Jordan Safirstein, MD

Morristown Memorial Hospital
Morristown, NJ United States
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Kayvan Ellini, MD

Presbyterian Hospital
Albuquerque, NM United States
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Loukas Boutis, MD

North Shore University Hospital
Manhasset, NY United States
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Michael Attubato, MD

New York University Medical Center
New York, NY United States
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Manish Parikh, MD

Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, NY United States
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Ronald Caputo, MD

St. Joseph's Hospital Health Center
Syracuse, NY United States
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Michael Rinaldi, MD

Carolinas Medical Center
Charlotte, NC United States
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Islam Othman, MD

Wake Medical Center
Raleigh, NC United States
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Dean Kereiakes, MD

Lindner Center for Research and Education at Christ Hospital
Cincinnati, OH United States
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Dogan Temizer, MD

Good Samaritan Hospital
Cincinnati, OH United States
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Cindy Baker, MD

Ohio State University Medical Center
Columbus, OH United States
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Steven Yakubov, MD

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, OH United States
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Ameer Kabour, MD

Mercy St. Vincent Medical Center
Toledo, OH United States
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George Chrysant, MD

Integris Baptist Medical Center
Oklahoma City, OK United States
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Naeem Tahirkheli, MD

Oklahoma Heart Hospital
Oklahoma City, OK United States
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Ethan Korngold, MD

Providence St. Vincent Medical Center
Portland, OR United States
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James Blankenship, MD

Geisinger Medical Center
Danville, PA United States
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Saul Silver, MD

University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Timothy Shapiro, MD

Lankenau Hospital
Wynnewood, PA United States
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Michael Foster, MD

Sisters of Charity Providence Hospital
Columbia, SC United States
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Joseph Henderson, MD

University Medical Center-Greenville Memorial Hospital
Greenville, SC United States
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Randy Goodroe, MD

Grand Strand Regional Medical Center
Myrtle Beach, SC United States
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Henry Lui, MD

Jackson-Madison County General Hospital
Jackson, TN United States
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Brian Jefferson, MD

Centennial Medical Center
Nashville, TN United States
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Robert Stoler, MD

Baylor Heart & Vascular Hospital
Dallas, TX United States
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Ali Mortazavi, MD

St. Luke's Episcopal Hospital
Houston, TX United States
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Pranav Loyalka, MD

Memorial Hermann Southwest
Houston, TX United States
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Molly Szerlip, MD

The Heart Hospital Baylor Plano
Plano, TX United States
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Craig Siegel, MD

St. David's Round Rock Medical Center
Round Rock, TX United States
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Harold Dauerman, MD

The University of Vermont Medical Center
Burlington, VT United States
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Neville Mistry, MD

Sentara Norfolk General Hospital
Norfolk, VA United States
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Jason Call, MD

Winchester Medical Center
Winchester, VA United States
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Jeffrey Westcott, MD

Swedish Medical Center
Seattle, WA United States
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Creighton Don, MD

University of Washington Medical Center
Seattle, WA United States
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Elie Gharib, MD

Charleston Area Medical Center
Charleston, WV United States
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Suhail Allaqaband, MD

Aurora St. Luke's Medical Center
Milwaukee, WI United States
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Timothy Grady, MD

Aspirus Heart and Vascular Institute - Research and Education
Wausau, WI United States
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Pedro Lemos, MD

Instituto do Cora o (InCor)
Sao Paulo, Brazil
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Alexandre Antonio Cunha Abizaid, MD

Instituto de Cardiologia Dante Pazzanese
São Paulo, Brazil
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Franz-Josef Neumann, Prof, MD

Herzzentrum Bad Krozingen
Bad Krozingen, Germany
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Ralph Ernst Toelg, MD

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Bad Segeberg, Germany
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Raffi Bekeredjian, MD

Universitaetsklinikum Heidelberg
Heidelberg, Germany
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Christian Schultz, MD

Uni Jena
Jena, Germany
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Hiroyoshi Yokoi, MD

Fukuoka Sanno Hospital
Fukuoka-shi, Japan
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Peter Maurer

Iwate Medical University Hospital
Morioka-shi, Japan
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Yuji Ikari, MD

Tokai University Hospital
Isehara-shi, Japan
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Peter Maurer

Shonan Kamakura General Hospital
Kamakura-shi, Japan
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Yoshiaki Ito, MD

Saiseikai Yokohama-City Eastern Hospital
Yokohama-shi, Japan
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Peter Maurer

Mitsui Memorial Hospital
Chiyoda-ku, Japan
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Ken Kozuma, MD

Teikyo University Hospital
Itabashi-ku, Japan
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Masato Nakamura, MD

Toho University Ohashi Medical Center
Meguro-ku, Japan
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Peter Maurer

Kurume University Hospital
Kurume-shi, Japan
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Junya Shite, MD

Osaka Saiseikai Nakatsu Hospital
Osaka, Japan
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Andrejs Erglis, MD

P. Stradins University Hospital
Riga, Latvia
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Iwar Sjoegren, MD

Falu Lasarett
Falun, Sweden
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Hans Olsson, MD

Karlstadt Central Hospital
Karlstad, Sweden
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Matthias Goetberg, MD

Skane University Hospital
Malmo, Sweden
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Stephane Cook, MD

Hospital Cantonal Fribourg
Fribourg, Switzerland
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