EVOLVE Short DAPT Study
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|ClinicalTrials.gov Identifier: NCT02605447|
Recruitment Status : Completed
First Posted : November 16, 2015
Results First Posted : September 25, 2020
Last Update Posted : September 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: 3 months of dual antiplatelet therapy (DAPT) Device: SYNERGY Stent System||Phase 4|
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)|
|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|
|Actual Primary Completion Date :||July 17, 2019|
|Actual Study Completion Date :||July 17, 2019|
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
- Number of Participants Who Experienced Death or Myocardial Infarction (MI) [ Time Frame: 3 to 15 months ]Rate of death or myocardial infarction
- Number of Participants Who Experienced Stent Thrombosis (ST) [ Time Frame: 3 to 15 months ]
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.
- Number of Participants Who Experienced Major Bleeding [ Time Frame: 3 to 15 months ]
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
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
|Principal Investigator:||Ajay Kirtane, MD||Columbia University Medical Center/ NewYork Presbyterian Hospital|
|Principal Investigator:||Stephan Windecker, Prof, MD||INSELSPITAL - Universitätsspital Bern|