EVOLVE Short DAPT Study

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605447
• Other study ID #: S2073
• Status: Completed
• Phase: Phase 4
• Start date: February 16, 2016
• Est. completion date: July 17, 2019

Study information

• Verified date: September 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2009
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Subject must be at least 18 years of age

3. Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days

4. Subject must be able to take study required antiplatelet therapy (as required per protocol)

5. 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

6. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed

7. 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:

1. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)

2. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition

3. Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure

4. Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).

5. 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)

6. Subject with implantation of a drug-eluting stent within 9 months prior to index procedure

7. Subject previously treated at any time with intravascular brachytherapy

8. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding

9. 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)

10. 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)

11. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use

12. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure

13. Subject is a woman who is pregnant or nursing

14. Subject with a current medical condition with a life expectancy of less than 15 months

15. Target lesion(s) is located in the left main

16. 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

17. Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)

18. Planned treatment of more than 3 lesion

19. Planned treatment of lesions in more than 2 major epicardial vessels

20. Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)

21. Target lesion(s) is restenotic from a previous stent implantation

22. Target lesion(s) is located within a saphenous vein graft or an arterial graft

23. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing

24. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• 3 months of dual antiplatelet therapy (DAPT)
3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin

Device:
• SYNERGY Stent System
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Brazil,  Germany,  Japan,  Latvia,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced Death or Myocardial Infarction (MI)	Rate of death or myocardial infarction	3 to 15 months
Primary	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.	3 to 15 months
Secondary	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	3 to 15 months