Clinical trial NCT00638794: Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents
Official title: Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Myocardial Infarction
Myocardial Ischemia
Lead sponsor: Cardiovascular Research Foundation, New York
Sponsor class: OTHER
Collaborators: name: Dickson Advanced Analytics Group
First posted: 2008-03-19
Enrollment: 8575
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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).

Brief summary: 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.

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 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.

Primary outcomes:
measure: Definite or probable stent thrombosis using the Academic Research Consortium (ARC) definition, primary events only.
timeFrame: 30 days, 1 year, 2 year
Secondary outcomes:
measure: 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.
timeFrame: 1 day, 30 days, 1 year, 2 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center & New York Presbyterian
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Hospital
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital and Health Network
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
Study officials:
affiliation: CardioVascular Research Foundation
name: Gregg W. Stone, MD
role: PRINCIPAL_INVESTIGATOR
References:
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