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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 2008
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®, Endeaver™)

MedlinePlus related topics: Coronary Artery Disease
Drug Information available for: Paclitaxel Sirolimus
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents

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®, Endeaver™)
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

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 6 hours 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 33 and 52% and Platelet Count between 119,000 and 502,000/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. 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.
  3. Current enrollment in an investigational drug or device study that has not reached the time period of the primary endpoint.
  4. Patients in whom bypass graft surgery is planned within 2 years.
  5. Patients with stent thrombosis before the performance of pre-discharge VerifyNow platelet function testing.
  6. 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: Rosemary DeMarco, BSN (212) 851-9107 rdemarco@crf.org

Locations
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         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            
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

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, 2008
ClinicalTrials.gov Identifier: NCT00638794  
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:
Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Paclitaxel
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009