EVOLVE Short DAPT Study

Phase 4

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: 3 months of dual antiplatelet therapy (DAPT)
Device: SYNERGY Stent System

Registration Number: NCT02605447

Lead Sponsor: Boston Scientific Corporation

Brief Summary: 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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2009

Inclusion Criteria

Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:
- ≥ 75 years of age and, in the opinion of the investigator, the risk of major bleeding associated with >3 months of DAPT outweighs the benefit,
- need for chronic or lifelong anticoagulation,
- history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,
- history of stroke (ischemic or hemorrhagic),
- renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),
- platelet count ≤100,000/μL
Subject must be at least 18 years of age
Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days
Subject must be able to take study required antiplatelet therapy (as required per protocol)
Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol
Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed
For subjects less than 20 years of age enrolled at a Japanese site, the subject/ the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed

Exclusion Criteria

Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure
Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).
Subject has a known allergy to contrast (that cannot be adequately pre-medicated), the SYNERGY stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)
Subject with implantation of a drug-eluting stent within 9 months prior to index procedure
Subject previously treated at any time with intravascular brachytherapy
Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
Subject is participating in an investigational drug or device clinical trial that has not reached its primary endpoint (Note: registry, observational, data collection studies are not exclusionary)
Subject intends to participate in an investigational drug or device clinical trial within 15 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)
Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use
Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure
Subject is a woman who is pregnant or nursing
Subject with a current medical condition with a life expectancy of less than 15 months
Target lesion(s) is located in the left main
Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)
Planned treatment of more than 3 lesion
Planned treatment of lesions in more than 2 major epicardial vessels
Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)
Target lesion(s) is restenotic from a previous stent implantation
Target lesion(s) is located within a saphenous vein graft or an arterial graft
Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SYNERGY stent + 3 month DAPT	3 months of dual antiplatelet therapy (DAPT)	Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)
SYNERGY stent + 3 month DAPT	SYNERGY Stent System	Subject with implantation of at least one SYNERGY stent within the preceding 3 calendar days that takes the required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Death or Myocardial Infarction (MI)	3 to 15 months	Rate of death or myocardial infarction
Number of Participants Who Experienced Stent Thrombosis (ST)	3 to 15 months	Rate of stent thrombosis: definite + probable, using the Academic Research Consortium (ARC) definition Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed) Probable Clinical definition of probable stent thrombosis is considered to have occurred in the following cases: * Any unexplained death within the first 30 days * Irrespective of the time after the index procedure and MI in the absence of any obvious cause which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis Possible Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained death beyond 30 days.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Major Bleeding	3 to 15 months	Rate of Bleeding, per Bleeding Academic Consortium definition (BARC2, 3a, 3b, 3c, 4, 5a and 5b) * Type 0: No Bleeding * Type 1: Bleeding that is not actionable and does not cause the patient to seek treatment * Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional * Type 3a: Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding * Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents * Type 3c: Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision * Type 4: CABG-related bleeding within 48 hours * Type 5a: Probable fatal bleeding * Type 5b: Definite fatal bleeding

Trial Locations

Locations (110): Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States
Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States
Cedars - Sinai Medical Center
🇺🇸
Los Angeles, California, United States
HCA Riverside Community Hospital
🇺🇸
Riverside, California, United States
John Muir Medical Center
🇺🇸
Walnut Creek, California, United States
South Denver Cardiology Associates, PC
🇺🇸
Littleton, Colorado, United States
Morton Plant Mease Healthcare System
🇺🇸
Clearwater, Florida, United States
Mercy Hospital Medical Center
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Des Moines, Iowa, United States
HealthEast St. Joseph's Hospital
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Saint Paul, Minnesota, United States
Columbia University Medical Center/ NewYork Presbyterian Hospital
🇺🇸
New York, New York, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Lankenau Hospital
🇺🇸
Wynnewood, Pennsylvania, United States
Baptist Memorial Hospital
🇺🇸
Memphis, Tennessee, United States
St. Luke's Episcopal Hospital
🇺🇸
Houston, Texas, United States
Lindner Center for Research and Education at Christ Hospital
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Cincinnati, Ohio, United States
Kaiser Foundation Hospital - San Francisco
🇺🇸
San Francisco, California, United States
Abbott Northwestern Hospital
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Minneapolis, Minnesota, United States
Centennial Medical Center
🇺🇸
Nashville, Tennessee, United States
North Shore University Hospital
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Manhasset, New York, United States
Baptist Health Medical Center (Little Rock)
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Little Rock, Arkansas, United States
Morristown Memorial Hospital
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Morristown, New Jersey, United States
Deborah Heart and Lung Center
🇺🇸
Browns Mills, New Jersey, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Fukuoka Sanno Hospital
🇯🇵
Fukuoka-shi, Fukuoka, Japan
Toho University Ohashi Medical Center
🇯🇵
Meguro-ku, Tokyo, Japan
Sisters of Charity Providence Hospital
🇺🇸
Columbia, South Carolina, United States
JFK Medical Center
🇺🇸
Atlantis, Florida, United States
Shonan Kamakura General Hospital
🇯🇵
Kamakura-shi, Kanagawa, Japan
Mitsui Memorial Hospital
🇯🇵
Chiyoda-ku, Tokyo, Japan
Dartmouth Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
The University of Vermont Medical Center
🇺🇸
Burlington, Vermont, United States
Tokai University Hospital
🇯🇵
Isehara-shi, Kanagawa, Japan
Saiseikai Yokohama-City Eastern Hospital
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Yokohama-shi, Kanagawa, Japan
P. Stradins University Hospital
🇱🇻
Riga, Latvia
Grand Strand Regional Medical Center
🇺🇸
Myrtle Beach, South Carolina, United States
Banner Good Samaritan Regional Medical Center
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Phoenix, Arizona, United States
St. Joseph's Hospital & Medical Center
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Phoenix, Arizona, United States
Henry Ford Hospital
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Detroit, Michigan, United States
Aurora St. Luke's Medical Center
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Milwaukee, Wisconsin, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Wellstar Kennestone Hospital
🇺🇸
Marietta, Georgia, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
USC Medical Center
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Los Angeles, California, United States
Bakersfield Memorial Hospital
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Bakersfield, California, United States
El Camino Hospital
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Mountain View, California, United States
Mediquest Research at Munroe Regional Medical Center
🇺🇸
Ocala, Florida, United States
Tallahassee Memorial Hospital
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Tallahassee, Florida, United States
North Florida Regional Medical Center
🇺🇸
Gainesville, Florida, United States
Memorial Regional Hospital
🇺🇸
Hollywood, Florida, United States
University Hospital
🇺🇸
Augusta, Georgia, United States
Northern Indiana Research Alliance - Lutheran Hospital
🇺🇸
Fort Wayne, Indiana, United States
Medical Center of Central Georgia
🇺🇸
Macon, Georgia, United States
Kootenai Medical Center
🇺🇸
Coeur d'Alene, Idaho, United States
Florida Hospital Heartland Medical Center
🇺🇸
Sebring, Florida, United States
Edward Hospital
🇺🇸
Naperville, Illinois, United States
St. John's Hospital
🇺🇸
Springfield, Illinois, United States
Franciscan St. Francis Hospital
🇺🇸
Beech Grove, Indiana, United States
Carle Foundation Hospital
🇺🇸
Urbana, Illinois, United States
Community Heart and Vascular Hospital
🇺🇸
Indianapolis, Indiana, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Cardiovascular Research, LLC
🇺🇸
Shreveport, Louisiana, United States
St. Mary's Duluth Clinic Regional Heart Center
🇺🇸
Duluth, Minnesota, United States
Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
Cox Medical Centers
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Springfield, Missouri, United States
St. Joseph's Hospital Health Center
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Syracuse, New York, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
New York University Medical Center
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New York, New York, United States
Carolinas Medical Center
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Charlotte, North Carolina, United States
Wake Medical Center
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Raleigh, North Carolina, United States
Good Samaritan Hospital
🇺🇸
Cincinnati, Ohio, United States
Integris Baptist Medical Center
🇺🇸
Oklahoma City, Oklahoma, United States
Providence St. Vincent Medical Center
🇺🇸
Portland, Oregon, United States
Mercy St. Vincent Medical Center
🇺🇸
Toledo, Ohio, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
Oklahoma Heart Hospital
🇺🇸
Oklahoma City, Oklahoma, United States
Jackson-Madison County General Hospital
🇺🇸
Jackson, Tennessee, United States
Baylor Heart & Vascular Hospital
🇺🇸
Dallas, Texas, United States
St. David's Round Rock Medical Center
🇺🇸
Round Rock, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
Winchester Medical Center
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Winchester, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Swedish Medical Center
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Seattle, Washington, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Charleston Area Medical Center
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Charleston, West Virginia, United States
Instituto de Cardiologia Dante Pazzanese
🇧🇷
São Paulo, Brazil
Aspirus Heart and Vascular Institute - Research and Education
🇺🇸
Wausau, Wisconsin, United States
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
🇩🇪
Bad Segeberg, Germany
Instituto do Coração (InCor)
🇧🇷
Sao Paulo, Brazil
Herzzentrum Bad Krozingen
🇩🇪
Bad Krozingen, Germany
Universitaetsklinikum Heidelberg
🇩🇪
Heidelberg, Germany
Uni Jena
🇩🇪
Jena, Germany
Iwate Medical University Hospital
🇯🇵
Morioka-shi, Iwate-ken, Japan
Teikyo University Hospital
🇯🇵
Itabashi-ku, Tokyo, Japan
Kurume University Hospital
🇯🇵
Kurume-shi, Japan
Osaka Saiseikai Nakatsu Hospital
🇯🇵
Osaka, Japan
Hospital Cantonal Fribourg
🇨🇭
Fribourg, Switzerland
Falu Lasarett
🇸🇪
Falun, Sweden
Skane University Hospital
🇸🇪
Malmo, Sweden
Karlstadt Central Hospital
🇸🇪
Karlstad, Sweden
Sutter Medical Center, Sacramento
🇺🇸
Sacramento, California, United States
University of California, Davis Medical Center
🇺🇸
Sacramento, California, United States
Yale-New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Jewish Hospital and St. Mary's Healthcare
🇺🇸
Louisville, Kentucky, United States
St. Luke's Hospital of Kansas City
🇺🇸
Kansas City, Missouri, United States
Presbyterian Hospital
🇺🇸
Albuquerque, New Mexico, United States
University Medical Center-Greenville Memorial Hospital
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Greenville, South Carolina, United States