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Coronary Artery DiseasePhase 4NCT02605447

EVOLVE Short DAPT Study

A Phase 4 study testing 3 months of dual antiplatelet therapy (DAPT) and SYNERGY Stent System in people with Coronary Artery Disease, run by Boston Scientific Corporation at 110 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
3 months of dual antiplatelet therapy (DAPT) and SYNERGY Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,009 participants
Where
110 sitesin 7 countries
Study dates
16 Feb 2016to 17 Jul 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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),
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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)

Trial locations and contacts

110 sites in 7 countries.

110 sites in 7 countries

United States89 sites

  • Presbyterian Hospital

    Albuquerque, New Mexico, 87106

  • JFK Medical Center

    Atlantis, Florida, 33462

  • University Hospital

    Augusta, Georgia, 30901

  • Bakersfield Memorial Hospital

    Bakersfield, California, 93301

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Franciscan St. Francis Hospital

    Beech Grove, Indiana, 46237

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Lindner Center for Research and Education at Christ Hospital

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Morton Plant Mease Healthcare System

    Clearwater, Florida, 33756

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Sisters of Charity Providence Hospital

    Columbia, South Carolina, 29204

  • Ohio State University Medical Center

    Columbus, Ohio, 03210

  • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Baylor Heart & Vascular Hospital

    Dallas, Texas, 75226

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Mercy Hospital Medical Center

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. Mary's Duluth Clinic Regional Heart Center

    Duluth, Minnesota, 55805

  • Northern Indiana Research Alliance - Lutheran Hospital

    Fort Wayne, Indiana, 46804

  • North Florida Regional Medical Center

    Gainesville, Florida, 32605

  • University Medical Center-Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Community Heart and Vascular Hospital

    Indianapolis, Indiana, 46250

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-1000

  • Baptist Health Medical Center (Little Rock)

    Little Rock, Arkansas, 72205

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates, PC

    Littleton, Colorado, 80120

  • USC Medical Center

    Los Angeles, California, 90033

  • Cedars - Sinai Medical Center

    Los Angeles, California, 90048

  • Jewish Hospital and St. Mary's Healthcare

    Louisville, Kentucky, 40202

  • Medical Center of Central Georgia

    Macon, Georgia, 31201

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07960

  • El Camino Hospital

    Mountain View, California, 94040

  • Grand Strand Regional Medical Center

    Myrtle Beach, South Carolina, 29572

  • Edward Hospital

    Naperville, Illinois, 60566

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • New York University Medical Center

    New York, New York, 10016

  • Columbia University Medical Center/ NewYork Presbyterian Hospital

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Mediquest Research at Munroe Regional Medical Center

    Ocala, Florida, 34471

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • Banner Good Samaritan Regional Medical Center

    Phoenix, Arizona, 85006

  • St. Joseph's Hospital & Medical Center

    Phoenix, Arizona, 85013

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Wake Medical Center

    Raleigh, North Carolina, 27610

  • HCA Riverside Community Hospital

    Riverside, California, 92506

  • St. David's Round Rock Medical Center

    Round Rock, Texas, 78681

  • Sutter Medical Center, Sacramento

    Sacramento, California, 95816

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • Kaiser Foundation Hospital - San Francisco

    San Francisco, California, 94115

  • Swedish Medical Center

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Florida Hospital Heartland Medical Center

    Sebring, Florida, 33870

  • Cardiovascular Research, LLC

    Shreveport, Louisiana, 71103

  • St. John's Hospital

    Springfield, Illinois, 62701

  • Cox Medical Centers

    Springfield, Missouri, 65802

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • St. Joseph's Hospital Health Center

    Syracuse, New York, 13202

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Mercy St. Vincent Medical Center

    Toledo, Ohio, 43608

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • John Muir Medical Center

    Walnut Creek, California, 94598

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Aspirus Heart and Vascular Institute - Research and Education

    Wausau, Wisconsin, 54401

  • Winchester Medical Center

    Winchester, Virginia, 26015

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Japan10 sites

  • Mitsui Memorial Hospital

    Chiyoda-ku, Tokyo, 101-8643

  • Fukuoka Sanno Hospital

    Fukuoka, Fukuoka, 814-0001

  • Tokai University Hospital

    Isehara-shi, Kanagawa, 259-1193

  • Teikyo University Hospital

    Itabashi-ku, Tokyo, 173-8606

  • Shonan Kamakura General Hospital

    Kamakura-shi, Kanagawa, 247-0072

  • Kurume University Hospital

    Kurume-shi, 830-0011

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo, 153-8515

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Osaka Saiseikai Nakatsu Hospital

    Osaka

  • Saiseikai Yokohama-City Eastern Hospital

    Yokohama, Kanagawa, 230-8765

Other trials in Japan

Germany4 sites

  • Herzzentrum Bad Krozingen

    Bad Krozingen, 79189

  • Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

    Bad Segeberg, 23795

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Uni Jena

    Jena, 07740

Other trials in Germany

Sweden3 sites

  • Falu Lasarett

    Falun, 79182

  • Karlstadt Central Hospital

    Karlstad, 65185

  • Skane University Hospital

    Malmö, SE-214 28

Other trials in Sweden

Brazil2 sites

  • Instituto de Cardiologia Dante Pazzanese

    São Paulo, 04012-909

  • Instituto do Coração (InCor)

    São Paulo, 05403-000

Other trials in Brazil

Latvia1 site

  • P. Stradins University Hospital

    Riga, LV-1002

Other trials in Latvia

Switzerland1 site

  • Hospital Cantonal Fribourg

    Fribourg, 1708

Other trials in Switzerland

About this study

Official title: A Prospective, Multicenter, Single-arm Study Designed 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 Everolimus-Eluting Platinum Chromium Coronary Stent System

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.

Read the 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.

Being tested
3 months of dual antiplatelet therapy (DAPT), SYNERGY Stent System
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 months of dual antiplatelet therapy (DAPT)Drug

    3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin

  • SYNERGY Stent SystemDevice

    SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

Study groups in NCT02605447
Study groupRoleWhat they receive
SYNERGY stent + 3 month DAPTExperimentalSubject 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)
Receives: Drug: 3 months of dual antiplatelet therapy (DAPT); Device: SYNERGY Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experienced Death or Myocardial Infarction (MI)

    Rate of death or myocardial infarction

    Measured: 3 to 15 months

  2. Number of Participants Who Experienced Stent Thrombosis (ST)

    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.

    Measured: 3 to 15 months

Secondary outcomes (1)

  1. Number of Participants Who Experienced Major Bleeding

    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

    Measured: 3 to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2015 (estimated)
  2. Study start16 Feb 2016
  3. Primary completion17 Jul 2019
  4. Study completion17 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,009 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02605447
Sponsor's protocol ID
S2073
Status last verified
Sep 2020
First submitted
12 Nov 2015
Last updated
25 Sep 2020
Data monitoring committee
Yes

Publications

  • Mihatov N, Kirtane AJ, Stoler R, Feldman R, Neumann FJ, Boutis L, Tahirkheli N, Kereiakes DJ, Toelg R, Othman I, Stein B, Allocco D, Windecker S, Yeh RW. Bleeding and Ischemic Risk Prediction in Patients With High Bleeding Risk (an EVOLVE Short DAPT Analysis). Am J Cardiol. 2023 Nov 15;207:370-379. doi: 10.1016/j.amjcard.2023.06.036. Epub 2023 Sep 29.

    PubMed 37778226

  • Kirtane AJ, Stoler R, Feldman R, Neumann FJ, Boutis L, Tahirkheli N, Toelg R, Othman I, Stein B, Choi JW, Windecker S, Yeh RW, Dauerman HL, Price MJ, Underwood P, Allocco D, Meredith I, Kereiakes DJ. Primary Results of the EVOLVE Short DAPT Study: Evaluation of 3-Month Dual Antiplatelet Therapy in High Bleeding Risk Patients Treated With a Bioabsorbable Polymer-Coated Everolimus-Eluting Stent. Circ Cardiovasc Interv. 2021 Mar;14(3):e010144. doi: 10.1161/CIRCINTERVENTIONS.120.010144. Epub 2021 Mar 1.

    PubMed 33641374

  • Balanescu DV, Aziz MK, Donisan T, Palaskas N, Lopez-Mattei J, Hassan S, Kim P, Song J, Ntim W, Cilingiroglu M, Marmagkiolis K, Iliescu C. Cancer treatment resumption in patients with new-generation drug-eluting stents. Coron Artery Dis. 2021 Jun 1;32(4):295-301. doi: 10.1097/MCA.0000000000000986.

    PubMed 33196581

  • Mauri L, Kirtane AJ, Windecker S, Yeh RW, Dauerman HL, Price MJ, Christen T, Allocco DJ, Meredith IT, Kereiakes DJ. Rationale and design of the EVOLVE Short DAPT Study to assess 3-month dual antiplatelet therapy in subjects at high risk for bleeding undergoing percutaneous coronary intervention. Am Heart J. 2018 Nov;205:110-117. doi: 10.1016/j.ahj.2018.08.004. Epub 2018 Aug 17.

    PubMed 30218844

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 3 months of dual antiplatelet therapy (DAPT) and SYNERGY Stent System in people with Coronary Artery Disease, run by Boston Scientific Corporation at 110 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, Japan, Germany, Sweden, Brazil and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced Death or Myocardial Infarction (MI) (time frame: 3 to 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02605447, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.

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EVOLVE Short DAPT Study (NCT02605447) | AzTrials