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Trial record 1 of 1 for:    SynIVUS
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SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month (SYNIVUS-DAPT)

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ClinicalTrials.gov Identifier: NCT03606642
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : November 29, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
HonorHealth Research Institute

Tracking Information
First Submitted Date  ICMJE July 23, 2018
First Posted Date  ICMJE July 31, 2018
Last Update Posted Date November 29, 2019
Actual Study Start Date  ICMJE November 19, 2018
Estimated Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Rate of cardiac death [ Time Frame: 1 to 13 months ]
    Rate of cardiac death from 1 to 13 months post-index procedure in the "as treated" (eligible for 30 day DAPT cessation) population.
  • Rate of myocardial infarction [ Time Frame: 1 to 13 months ]
    Rate of myocardial infarction (SCAI definition) from 1 to 13 months post-index procedure in the overall enrolled "intent-to-treat" patient population
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Rate of Academic Research Consortium (ARC) definite/probable stent thrombosis (ST) [ Time Frame: 1 to 13 months ]
    Rate of Academic Research Consortium (ARC) definite/probable stent thrombosis (ST) involving SYNERGY Stent® from 1 to 13 months post-index procedure
  • Rate of major bleeding [ Time Frame: 1 to 13 months ]
    Rate of major bleeding (GUSTO severe/life threatening + moderate)
  • Ischemia-Driven (ID) Target Lesion Revascularization [ Time Frame: 1 to 13 months ]
    Angina Assessment
  • ID Target Vessel Revascularization, [ Time Frame: 1 to 13 months ]
    Angina Assessment
  • Target Lesion Failure [ Time Frame: 1 to 13 months ]
    Angina Assessment
  • Target Vessel Failure [ Time Frame: 1 to 13 months ]
    Angina Assessment
  • All-Cause Death [ Time Frame: 1 to 13 months ]
    Angina Assessment
  • All-Cause MI [ Time Frame: 1 to 13 months ]
    Angina Assessment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month
Official Title  ICMJE SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month
Brief Summary The purpose of this study is to see if one month of dual antiplatelet therapy (DAPT) combined with the placement of the Synergy® Stent with IVUS (intravascular ultrasound) is safe for patients who are at high risk of bleeding (HBR).
Detailed Description

DAPT or Dual Antiplatelet Therapy is a combination of two medications given after a percutaneous coronary intervention (PCI) with a drug eluting stent. DAPT is used to help make the platelets in your blood slick so they don't clump or stick together. If the platelets stick together and form a blood clot in the stent it is called a stent thrombosis and will cause an immediate heart attack or MI.

The medications used for DAPT are low dose Aspirin (81mg) and one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) . The standard length of time to take DAPT after a stent placement is 6 months to 1 year. Dapt is associated with an increased risk of bleeding. Because you are considered to be at a high risk for bleeding due to one or a combination of reasons this study is trying to determine if a shorter use of DAPT in combination with the Synergy® stent and an imaging tool called IVUS used during your PCI procedure is safe and effective to reduce the potential for serious bleeding events and early stent thrombosis.

The Synergy® stent was chosen because of its enhanced method of healing and reduced inflammation of the artery after placement. Because of this the Synergy stent may be a better choice for patients who are at high risk for bleeding and could benefit from a shortened period of DAPT.

Intravascular ultrasound or IVUS provides a visual image of the inside of the coronary artery. It is used in patients undergoing PCI or stent placement for a few reasons; prior to placing the stent it is used to measure the artery's width to select the proper size diameter of a stent, also the length of the blockage to select the appropriate length of the stent and to visualize the amount of narrowing or blockage. After the stent is placed IVUS is used to make sure the stent itself is fully expanded and sits up against the wall of the artery. This is called apposition. If stents are not fully expanded and sit up against the wall of the artery early reblockage may occur. In short the IVUS aids in the ideal placement of the stent.

By using the combination of the Synergy® Stent with the IVUS the expectation is to safely decrease the length of time you take DAPT from 6-12 months to 1 month. With the benefit of decreasing the risk of bleeding events.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
DAPT or Dual Antiplatelet Therapy is a combination of two medications given after a percutaneous coronary intervention (PCI) with a drug eluting stent. The medications used for DAPT are low dose Aspirin (81mg) and one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient). Because the patients are considered to be at a high risk for bleeding due to one or a combination of reasons this study is trying to determine if a shorter use of DAPT in combination with the Synergy® stent and an imaging tool called IVUS used during your PCI procedure is safe and effective to reduce the potential for serious bleeding events and early stent thrombosis. The Synergy® stent was chosen because of its enhanced method of healing and reduced inflammation of the artery after placement. The Synergy stent may be a better choice for patients who are at high risk for bleeding and could benefit from a shortened period of DAPT.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Atherosclerosis
  • Stent Placement
Intervention  ICMJE
  • Drug: Dual Antiplatelet (DAPT) Therapy

    DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.

    Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.

    P2Y12 Inhibitor Loading Dose (investigator preference):

    Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.

    P2Y12 Inhibitor Maintenance Dose (investigator preference):

    Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.

  • Device: The Synergy® stent
    IVUS guided stent
Study Arms  ICMJE Experimental: PCI with 30 day DAPT Therapy
Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose [if applicable] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)
Interventions:
  • Drug: Dual Antiplatelet (DAPT) Therapy
  • Device: The Synergy® stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 23, 2021
Estimated Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 bleeding associated with >1 months of DAPT outweighs the benefit,
  • need for chronic or lifelong anticoagulation therapy
  • 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
  • In the opinion of investigator, patient is at significant risk of falling
  • Patient abuses drugs or alcohol 2. Subject must be 18 years of age 3. Subject must have had implantation of at least one SYNERGY Stent®s and the use of Boston Scientific IVUS 4. Subject must be able to take study required dual antiplatelet therapy (1 month of P2Y12 inhibitor and aspirin, 13 months of antiplatelet monotherapy) 5. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 1-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 trial-specific procedures are performed 7. Patients must meet the following IVUS success criteria:

    1. treated lesions in which the stent cross sectional area exceeds the distal reference cross sectional area
    2. Otherwise additional post-dilatation should be performed, followed by repeat IVUS.

Exclusion Criteria:

  1. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
  2. Index procedure Saphenous vein graft lesion treatment
  3. TIMI flow 0 (total occlusion)
  4. With the exception of peri-procedural Non Q-wave MI, a Subject that has a clinical event (Cardiac Death, MI, ARC Def/Prob ST, repeat PCI or CABG) within 30 days of index procedure will not be eligible for DAPT cessation, but will be followed in the trial, yet not included in the primary endpoint analysis. They will be included in a secondary endpoint analysis
  5. Subject with treatment with another coronary stent, other than SYNERGY Stent®s, during the index procedure
  6. Subject who did not receive Boston Scientific IVUS guided stent implantation and assessment
  7. Patients undergoing planned staged procedures are excluded if performed >7 days following the index procedure. Staged procedures within 7 days of the index procedure are permitted only if SYNERGY stents are used. Discontinuation of DAPT should occur 1 month after the last PCI procedure is completedSubject with planned staged procedures. Note: Patients undergoing planned staged procedures are excluded if performed > 7 days following the index procedure or if SYNERGY stents are not used)
  8. Subject has a known allergy to: contrast (that cannot be adequately pre-medicated), the SYNERGY Stent®s system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)
  9. Subject previously treated at any time with intravascular brachytherapy
  10. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
  11. 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)
  12. Subject intends to participate in an investigational drug or device clinical trial within 12 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)
  13. Subject is judged inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use
  14. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure
  15. Subject is a woman who is pregnant or nursing
  16. Subject with a current medical condition with a life expectancy of less than 12 months
  17. Subject with Non ST elevation MI (NSTEMI) at the time of the index procedure , based on the 3rd Universal MI definition
  18. Subject with implantation of a drug-eluting stent other than SYNERGY Stent®s within 11 months prior to index procedure
  19. Target lesion(s) is located in the left main
  20. Potential Target lesion(s) that involve a complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)
  21. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
  22. Have been previously consented for this trial and screen failed
  23. Patients requiring a treatment of more than two native epicardial vessels with a maximum of two lesions per vessel. Each treated lesion requires Boston Scientific IVUS guided stenting.
  24. Patients who do not meet the following IVUS success criteria:

    1. treated lesions in which the stent cross sectional area exceeds the distal reference cross sectional area
    2. Otherwise additional post-dilatation should be performed, followed by repeat IVUS.
  25. Treatment of non-target lesions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joanne Saczynski, RN 480-323-1046 joanne.saczynski@honorhealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03606642
Other Study ID Numbers  ICMJE SYNIVUS-DAPT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party HonorHealth Research Institute
Study Sponsor  ICMJE HonorHealth Research Institute
Collaborators  ICMJE Boston Scientific Corporation
Investigators  ICMJE
Principal Investigator: David Rizik, MD HonorHealth Research Institute
PRS Account HonorHealth Research Institute
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP