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Trial record 1 of 1 for:    evolve short dapt
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EVOLVE Short DAPT Study

This study is currently recruiting participants.
Verified November 2017 by Boston Scientific Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02605447
First Posted: November 16, 2015
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease Drug: 3 months of dual antiplatelet therapy (DAPT) Device: SYNERGY Stent System Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Death or Myocardial Infarction (MI) [ Time Frame: 3 to 15 months ]
    Rate of death or myocardial infarction

  • Stent Thrombosis (ST) [ Time Frame: 3 to 15 months ]
    Rate of stent thrombosis: definite + probable, using the Academic Research Consortium (ARC) definition


Secondary Outcome Measures:
  • Major Bleeding [ Time Frame: 3 to 15 months ]
    Rate of Bleeding, per Bleeding Academic Consortium definition (BARC 2, 3, 5)


Estimated Enrollment: 2000
Study Start Date: January 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYNERGY stent + 3 month 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)
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

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,
    • 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 who is taking (or is planning to take) chronic or lifelong anticoagulation within 15 months following index procedure.
  2. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
  3. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
  4. Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure
  5. Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).
  6. 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)
  7. Subject with implantation of a drug-eluting stent within 9 months prior to index procedure
  8. Subject previously treated at any time with intravascular brachytherapy
  9. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
  10. 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)
  11. 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)
  12. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use
  13. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure
  14. Subject is a woman who is pregnant or nursing
  15. Subject with a current medical condition with a life expectancy of less than 15 months
  16. Target lesion(s) is located in the left main
  17. 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
  18. Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)
  19. Planned treatment of more than 3 lesion
  20. Planned treatment of lesions in more than 2 major epicardial vessels
  21. Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)
  22. Target lesion(s) is restenotic from a previous stent implantation
  23. Target lesion(s) is located within a saphenous vein graft or an arterial graft
  24. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
  25. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605447


Contacts
Contact: Peter Maurer 508-683-6678 Peter.Maurer@bsci.com
Contact: Kellie Windle 508-683-6616 Kellie.Windle@bsci.com

  Show 113 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Laura Mauri, MD, MSc Brigham and Women's Hospital
Principal Investigator: Ajay Kirtane, MD Columbia University Medical Center/ NewYork Presbyterian Hospital
Principal Investigator: Stephan Windecker, Prof, MD INSELSPITAL - Universitätsspital Bern
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02605447     History of Changes
Other Study ID Numbers: S2073
First Submitted: November 12, 2015
First Posted: November 16, 2015
Last Update Posted: November 21, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Chromium
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances