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Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents (ADAPT-DES)
This study is currently recruiting participants.
Verified by Cardiovascular Research Foundation, New York, March 2009
First Received: February 28, 2008   Last Updated: March 18, 2009   History of Changes
Sponsors and Collaborators: Cardiovascular Research Foundation, New York
R. Stuart Dickson Institute for Health Studies
Information provided by: Cardiovascular Research Foundation, New York
ClinicalTrials.gov Identifier: NCT00638794
  Purpose

Prospective, multicenter, registry of at least 11,000 (and up to 15,000) consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.


Condition Intervention
Coronary Artery Disease
Device: Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)

Study Type: Observational
Study Design: Prospective
Official Title: Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents

Resource links provided by NLM:


Further study details as provided by Cardiovascular Research Foundation, New York:

Primary Outcome Measures:
  • Definite or probable stent thrombosis using the Academic Research Consortium (ARC) definition, primary events only. [ Time Frame: 30 days, 1 year, 2 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ARC definite, probable, possible or any stent thrombosis, utilizing primary only and then primary + secondary thromboses; death, MI, recurrent ischemia necessitating repeat target lesion and target vessel intervention and MACE. [ Time Frame: 1 day, 30 days, 1 year, 2 year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 11000
Study Start Date: January 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgical
Patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.
Observational
Consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications
Device: Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)
PCI using any FDA approved drug-eluting stent; Taxus Express2 - Paclitaxel-Eluting Coronary Stent System Cypher Sirolimus-eluting coronary stent Endeavor ABT-578 Eluting Coronary Stent System Xience V Everolimus Eluting Coronary Stent System

Detailed Description:

To determine:

  1. the frequency, timing and correlates (clinical and angiographic) of drug-eluting stent (DES) thrombosis in a patient population with few clinical and angiographic exclusion criteria,
  2. the relationship of aspirin and/or clopidogrel hyporesponsiveness, and general platelet reactivity to early and late DES thrombosis in separate phases stratified by whether the patient is taking dual (aspirin plus clopidogrel) or single (aspirin alone) antiplatelet therapy, and
  3. combining the findings from the above 2 objectives, to identify a cohort representing a significant proportion of all patients at increased risk to have early and/or late DES stent thrombosis.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient undergoing PCI in whom at least one DES is implanted and in whom PCI of all treated lesions is successful (diameter stenosis <30% with TIMI 3 flow in all treated lesions) without major complications (defined as freedom from procedural death, intraprocedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery).

Criteria

Inclusion Criteria:

  1. Patients undergoing PCI in whom at least one DES is implanted and in whom PCI of all treated lesions is successful (diameter stenosis <30% with TIMI 3 flow in all treated lesions) without major complications (defined as freedom from procedural death, intra-procedural stent thrombosis, procedural myocardial infarction or sustained vessel closure, or need for emergency bypass graft surgery). One or more bare metal stents (BMS) may be implanted, and other lesions may be treated without stenting as long as at least one DES is implanted.

    However, the procedure must be successful and uncomplicated (as defined above) for all lesions (DES + BMS + non-stent).

  2. Aspirin use: Adequate aspirin loading given prior to PCI: at least 300 mg non enteric coated oral aspirin at least 1 hour prior to the procedure or 324 mg chewed or 250 mg IV aspirin at least 30 minutes prior to the procedure.
  3. Patient has Hematocrit between 30 and 52% and Platelet Count greater than 100,000/µl.
  4. For US sites: Only FDA-approved DES stents may be used in this study. For OUS sites: Only DES stents that are CE marked for approval may be used in this study.
  5. PCI performed with unfractionated or low molecular weight heparin, or bivalirudin as the procedural antithrombin.
  6. Patient or guardian able to provide informed written consent.

Exclusion Criteria:

  1. Patients in whom blood for Accumetrics VerifyNow platelet function testing cannot be drawn after the minimum clopidogrel loading duration and Glycoprotein (GP) IIb/IIIa inhibitor washout duration as follows:

    1. Clopidogrel loading: Clopidogrel loading pre PCI is recommended, but post PCI clopidogrel loading is acceptable per standard of care. In all patients (whether or not clopidogrel is initiated pre or post PCI), prior to blood drawing for VerifyNow platelet function testing, a 600 mg loading dose must have been given at least 6 hours prior, or a 300 mg loading dose must have been given at least 12 hours prior, or the patient must have been maintained on at least 75 mg of clopidogrel daily for at least 5 days.
    2. GP IIb/IIIa inhibitor washout: Eptifibatide or tirofiban must have been discontinued for at least 24 hours prior to VerifyNow platelet function testing. Abciximab must have been discontinued for at 10 days prior to VerifyNow platelet function testing.
  2. Inability of the VerifyNow system to measure either Aspirin, P2Y12 or IIb/IIIa platelet responsiveness.
  3. Severe allergy to stainless steel, contrast dye, all anti-thrombin agents (unfractionated and low molecular weight heparin and bivalirudin), aspirin or clopidogrel that cannot be adequately pre-medicated.
  4. Concurrent enrollment in another trial that involves an investigational stent, antithrombotic or antiplatelet agent. Patient in other investigational trials that have not reached their primary endpoint may be enrolled in ADAPT-DES as long as the other trials do not involve an investigational stent, antithrombotic or antiplatelet agent and inclusion of such patient will have no effect on the endpoint of either study.
  5. Patients in whom bypass graft surgery is planned within 2 years.
  6. Patients with stent thrombosis before the performance of pre-discharge VerifyNow platelet function testing.
  7. Patients unwilling or unable to complete clinical follow-up for the duration of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638794

Contacts
Contact: Gregg W Stone, MD (212) 851-9302 gstone@crf.org
Contact: Louise Gambone (212) 851-9390 lgambone@crf.org

Locations
United States, Indiana
Indiana Heart Institute Withdrawn
Indianapolis, Indiana, United States, 46260
United States, Minnesota
Minneapolis Heart Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Tim Henry, MD     612-863-3834     henry003@umn.edu    
Contact: Dave Chose     612-863-3834     david.chose@allina.com    
Principal Investigator: Tim Henry, MD            
Sub-Investigator: Ivan Chavez, MD            
United States, New York
Columbia University Medical Center & New York Presbyterian Recruiting
New York, New York, United States, 10027
Contact: Giora Weisz, MD     212-305-2500        
Contact: Andy Morales     212-342-1820     am2513@columbia.edu    
Principal Investigator: Giora Weisz, MD            
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28202
Contact: Michael Rinaldi, MD     704-355-3188     mrinaldi@carolinashealthcare.org    
Contact: Craig McGregor     704-355-1359     Craig.McGregor@carolinashealthcare.org    
Principal Investigator: Michael Rinaldi, MD            
LeBauer Cardiovascular Research Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Bruce Brodie, MD     336-832-2546        
Contact: Barbara Bradshaw         barbara.bradshaw@mosescone.com    
Principal Investigator: Bruce Brodie, MD            
Sub-Investigator: Thomas Stuckey, MD            
FirstHealth Moore Regional Hospital Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Peter Duffy, MD     910-715-1591     pld@nc.rr.com    
Contact: Karen Borak     910-715-1591     kborak@firsthealth.org    
Principal Investigator: Peter Duffy, MD            
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Sean Miller     614-247-2127     sean.miller2@osumc.edu    
Principal Investigator: Ernest Mazzaferri, MD            
United States, Pennsylvania
Lehigh Valley Hospital and Health Network Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: David Cox, MD     610-402-2273     dcox@ptd.net    
Contact: Curt Trapp     610-402-8249     curtis.trapp@lvh.com    
Principal Investigator: David Cox, MD            
United States, Tennessee
Wellmont Holston Valley Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Christopher Metzger, MD     423-230-5000     cmetzger@theheartcenter.net    
Contact: Sarah Wilson     423-502-3273     swilson@theheartcenter.net    
Principal Investigator: Christopher Metzger, MD            
Sponsors and Collaborators
Cardiovascular Research Foundation, New York
R. Stuart Dickson Institute for Health Studies
Investigators
Principal Investigator: Gregg W. Stone, MD CardioVascular Research Foundation, Korea
  More Information

No publications provided

Responsible Party: Cardiovascular Research Foundation ( Gregg W. Stone, MD, Chairman, Cardiovascular Research Foundation )
Study ID Numbers: ADAPT-DES
Study First Received: February 28, 2008
Last Updated: March 18, 2009
ClinicalTrials.gov Identifier: NCT00638794     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Cardiovascular Research Foundation, New York:
Myocardial Infarction
Myocardial Ischemia

Study placed in the following topic categories:
Arterial Occlusive Diseases
Sirolimus
Everolimus
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Disease
Paclitaxel
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 10, 2009