Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents

Coronary Artery Disease Clinical Trial

— ADAPT-DES  

Official title:

Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638794
• Other study ID #: ADAPT-DES
• Status: Completed
• Phase: N/A
• First received: February 28, 2008
• Last updated: January 22, 2013
• Start date: January 2008
• Est. completion date: January 2013

Study information

• Verified date: August 2012
• Source: Cardiovascular Research Foundation, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8575
• Est. completion date: January 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital and Health Network	Allentown	Pennsylvania
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Ohio State University Medical Center	Columbus	Ohio
United States	LeBauer Cardiovascular Research	Greensboro	North Carolina
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Columbia University Medical Center & New York Presbyterian	New York	New York
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Cardiovascular Research Foundation, New York	Dickson Advanced Analytics Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Definite or probable stent thrombosis using the Academic Research Consortium (ARC) definition, primary events only.		30 days, 1 year, 2 year	Yes
Secondary	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.		1 day, 30 days, 1 year, 2 year	Yes