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EVOLVE Short DAPT Study

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ClinicalTrials.gov Identifier: NCT02605447
Recruitment Status : Active, not recruiting
First Posted : November 16, 2015
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2009 participants
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
Actual Study Start Date : February 16, 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Chromium

Arm Intervention/treatment
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




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

  2. 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 :
  1. Major Bleeding [ Time Frame: 3 to 15 months ]
    Rate of Bleeding, per Bleeding Academic Consortium definition (BARC 2, 3, 5)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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,
    • 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)

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


  Show 110 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Ajay Kirtane, MD Columbia University Medical Center/ NewYork Presbyterian Hospital
Principal Investigator: Stephan Windecker, Prof, MD INSELSPITAL - Universitätsspital Bern

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02605447     History of Changes
Other Study ID Numbers: S2073
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

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