Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents (ADAPT-DES)

This study has been completed.
Sponsor:
Collaborator:
Dickson Advanced Analytics Group
Information provided by (Responsible Party):
Cardiovascular Research Foundation, New York
ClinicalTrials.gov Identifier:
NCT00638794
First received: February 28, 2008
Last updated: January 22, 2013
Last verified: August 2012
  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: Time Perspective: 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 ]

Enrollment: 8575
Study Start Date: January 2008
Study Completion Date: January 2013
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
Other Name: Taxus™, Cypher®, Endeavor™, Xience V™

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638794

Locations
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, New York
Columbia University Medical Center & New York Presbyterian
New York, New York, United States, 10027
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28202
LeBauer Cardiovascular Research
Greensboro, North Carolina, United States, 27401
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, United States, 18105
United States, Tennessee
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660
Sponsors and Collaborators
Cardiovascular Research Foundation, New York
Dickson Advanced Analytics Group
Investigators
Principal Investigator: Gregg W. Stone, MD CardioVascular Research Foundation, Korea
  More Information

No publications provided by Cardiovascular Research Foundation, New York

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cardiovascular Research Foundation, New York
ClinicalTrials.gov Identifier: NCT00638794     History of Changes
Other Study ID Numbers: ADAPT-DES
Study First Received: February 28, 2008
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014