Coronary Artery DiseaseADAPT-DESNCT00638794

Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents

An observational study of Coronary Artery Disease, run by Cardiovascular Research Foundation, New York at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)
Type of treatment: Medical device
How many people: 8,575 participants
Where: 8 sitesUnited States
Study dates: Jan 2008to Jan 2013
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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).

Who may be able to join

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).
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.
Patient has Hematocrit between 30 and 52% and Platelet Count greater than 100,000/µl.
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.
PCI performed with unfractionated or low molecular weight heparin, or bivalirudin as the procedural antithrombin.
Patient or guardian able to provide informed written consent.

Who cannot join

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:
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.
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.
Inability of the VerifyNow system to measure either Aspirin, P2Y12 or IIb/IIIa platelet responsiveness.
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.
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.

Show all 9Show fewer

Patients in whom bypass graft surgery is planned within 2 years.
Patients with stent thrombosis before the performance of pre-discharge VerifyNow platelet function testing.
Patients unwilling or unable to complete clinical follow-up for the duration of the study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, 18105
Carolinas Medical Center
Charlotte, North Carolina, 28202
Ohio State University Medical Center
Columbus, Ohio, 43210
LeBauer Cardiovascular Research
Greensboro, North Carolina, 27401
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Columbia University Medical Center & New York Presbyterian
New York, New York, 10027
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374

Other trials in United States

About this study

Read the detailed description

To determine:

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,
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
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.

Conditions: Coronary Artery Disease
Being tested: Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)
Keywords: Myocardial Infarction, Myocardial Ischemia
Medical subject headings: Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)Device
Also called 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

Study groups in NCT00638794
Study group	Role	What they receive
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 Receives: Device: Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)

What is being measured

The primary outcome is the main question the study is designed to answer.

Definite or probable stent thrombosis using the Academic Research Consortium (ARC) definition, primary events only.
Measured: 30 days, 1 year, 2 year

Secondary outcomes (1)

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.
Measured: 1 day, 30 days, 1 year, 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jan 2013

First posted19 Mar 2008 (estimated)
Study startJan 2008
Primary completionDec 2011
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 8,575 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00638794
Sponsor's protocol ID: ADAPT-DES
Acronym: ADAPT-DES
Status last verified: Aug 2012
First submitted: 28 Feb 2008
Last updated: 23 Jan 2013
Results posted: No
Data monitoring committee: No

Publications

Shahim B, Redfors B, Stuckey TD, Liu M, Zhou Z, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Srdanovic I, Madhavan MV, Mazzaferri EL Jr, Mehran R, Ben-Yehuda O, Kirtane AJ, Stone GW. On-Treatment Platelet Reactivity and Ischemic Outcomes in Patients With Diabetes Mellitus: Two-Year Results From ADAPT-DES. J Am Heart Assoc. 2023 Jan 3;12(1):e026482. doi: 10.1161/JAHA.122.026482. Epub 2022 Dec 24.
PubMed 36565189
Redfors B, Kirtane AJ, Liu M, Musikantow DR, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Ben-Yehuda O, Mehran R, Stone GW. Dual Antiplatelet Therapy Discontinuation, Platelet Reactivity, and Adverse Outcomes After Successful Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2022 Apr 25;15(8):797-806. doi: 10.1016/j.jcin.2022.01.300.
PubMed 35450679
Gupta R, Kirtane AJ, Liu Y, Crowley A, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Mehran R, Ben-Yehuda O, Stone GW. Impact of Smoking on Platelet Reactivity and Clinical Outcomes After Percutaneous Coronary Intervention: Findings From the ADAPT-DES Study. Circ Cardiovasc Interv. 2019 Nov;12(11):e007982. doi: 10.1161/CIRCINTERVENTIONS.119.007982. Epub 2019 Nov 1.
PubMed 31672031
Maehara A, Mintz GS, Witzenbichler B, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri EL Jr, McAndrew T, Genereux P, Mehran R, Kirtane AJ, Stone GW. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents. Circ Cardiovasc Interv. 2018 Nov;11(11):e006243. doi: 10.1161/CIRCINTERVENTIONS.117.006243.
PubMed 30571206
Giustino G, Redfors B, Kirtane AJ, Mehran R, Dangas GD, Witzenbichler B, Neumann FJ, Weisz G, Genereux P, Maehara A, McAndrew T, Farhan S, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri EL Jr, Brodie BR, Stuckey TD, Gurbel P, Ben-Yehuda O, Stone GW. Platelet Reactivity and Risk of Ischemic Stroke After Coronary Drug-Eluting Stent Implantation: From the ADAPT-DES Study. JACC Cardiovasc Interv. 2018 Jul 9;11(13):1277-1286. doi: 10.1016/j.jcin.2018.01.263. Epub 2018 Jun 13.
PubMed 29908967
Redfors B, Genereux P, Witzenbichler B, Kirtane AJ, McAndrew T, Weisz G, Stuckey TD, Henry TD, Maehara A, Mehran R, Stone GW. Bleeding Severity After Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2018 Mar;11(3):e005542. doi: 10.1161/CIRCINTERVENTIONS.117.005542.
PubMed 29870382
Redfors B, Genereux P, Witzenbichler B, McAndrew T, Diamond J, Huang X, Maehara A, Weisz G, Mehran R, Kirtane AJ, Stone GW. Percutaneous Coronary Intervention of Saphenous Vein Graft. Circ Cardiovasc Interv. 2017 May;10(5):e004953. doi: 10.1161/CIRCINTERVENTIONS.117.004953.
PubMed 28495896
Gupta R, Kirtane AJ, Ozan MO, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Mehran R, Ben-Yehuda O, Stone GW. Platelet Reactivity and Clinical Outcomes After Coronary Artery Implantation of Drug-Eluting Stents in Subjects With Peripheral Arterial Disease: Analysis From the ADAPT-DES Study (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents). Circ Cardiovasc Interv. 2017 Mar;10(3):e004904. doi: 10.1161/CIRCINTERVENTIONS.116.004904.
PubMed 28288963
Yu J, Mehran R, Baber U, Ooi SY, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri EL Jr, Brodie BR, Stuckey TD, Maehara A, Xu K, Ben-Yehuda O, Kirtane AJ, Stone GW. Sex Differences in the Clinical Impact of High Platelet Reactivity After Percutaneous Coronary Intervention With Drug-Eluting Stents: Results From the ADAPT-DES Study (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents). Circ Cardiovasc Interv. 2017 Feb;10(2):e003577. doi: 10.1161/CIRCINTERVENTIONS.116.003577.
PubMed 28193677
Wang B, Mintz GS, Witzenbichler B, Souza CF, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Matsumura M, Yamamoto MH, Parvataneni R, Kirtane AJ, Stone GW, Maehara A. Predictors and Long-Term Clinical Impact of Acute Stent Malapposition: An Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) Intravascular Ultrasound Substudy. J Am Heart Assoc. 2016 Dec 22;5(12):e004438. doi: 10.1161/JAHA.116.004438.
PubMed 28007741
Kobayashi N, Mintz GS, Witzenbichler B, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Parvataneni R, Kirtane AJ, Stone GW, Maehara A. Prevalence, Features, and Prognostic Importance of Edge Dissection After Drug-Eluting Stent Implantation: An ADAPT-DES Intravascular Ultrasound Substudy. Circ Cardiovasc Interv. 2016 Jul;9(7):e003553. doi: 10.1161/CIRCINTERVENTIONS.115.003553.
PubMed 27402854
Yun KH, Mintz GS, Witzenbichler B, Inaba S, Shimizu T, Metzger DC, Rinaldi MJ, Mazzaferri EL Jr, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Kirtane AJ, Stone GW, Maehara A. Relationship Between Platelet Reactivity and Culprit Lesion Morphology: An Assessment From the ADAPT-DES Intravascular Ultrasound Substudy. JACC Cardiovasc Imaging. 2016 Jul;9(7):849-854. doi: 10.1016/j.jcmg.2015.08.019. Epub 2016 Feb 17.
PubMed 26897675
Kirtane AJ, Parikh PB, Stuckey TD, Xu K, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Mazzaferri EL Jr, Parvataneni R, Maehara A, Genereux P, Mehran R, Stone GW. Is There an Ideal Level of Platelet P2Y12-Receptor Inhibition in Patients Undergoing Percutaneous Coronary Intervention?: "Window" Analysis From the ADAPT-DES Study (Assessment of Dual AntiPlatelet Therapy With Drug-Eluting Stents). JACC Cardiovasc Interv. 2015 Dec 28;8(15):1978-1987. doi: 10.1016/j.jcin.2015.08.032.
PubMed 26738669
Dohi T, Maehara A, Witzenbichler B, Rinaldi MJ, Mazzaferri EL Jr, Duffy PL, Weisz G, Neumann FJ, Henry TD, Cox DA, Stuckey TD, Brodie BR, Litherland C, Brener SJ, Kirtane AJ, Mintz GS, Stone GW. Etiology, Frequency, and Clinical Outcomes of Myocardial Infarction After Successful Drug-Eluting Stent Implantation: Two-Year Follow-Up From the ADAPT-DES Study. Circ Cardiovasc Interv. 2015 Dec;8(12):e002447. doi: 10.1161/CIRCINTERVENTIONS.114.002447.
PubMed 26643737
Brodie BR, Garg A, Stuckey TD, Kirtane AJ, Witzenbichler B, Maehara A, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Mehran R, Parvataneni R, Stone GW. Fixed and Modifiable Correlates of Drug-Eluting Stent Thrombosis From a Large All-Comers Registry: Insights From ADAPT-DES. Circ Cardiovasc Interv. 2015 Oct;8(10):e002568. doi: 10.1161/CIRCINTERVENTIONS.114.002568.
PubMed 26415600

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents
ClinicalTrials.gov ID: NCT00638794
Acronym / sponsor ID: ADAPT-DES / ADAPT-DES
Conditions: Coronary Artery Disease
Keywords: Myocardial Infarction, Myocardial Ischemia
Study type: Observational
Recruitment status: Completed
Enrolment: 8,575 participants (actual)
Lead sponsor: Cardiovascular Research Foundation, New YorkUniversity, hospital or other
Collaborators: Dickson Advanced Analytics Group
Study start: Jan 2008
Primary completion: Dec 2011 (actual)
Study completion: Jan 2013 (actual)
First posted: 19 Mar 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To determine:

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,
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
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.

Study design

Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Surgical	–	–Patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.
Observational	–	Device: Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)Consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (6 listed)

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).
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.
Patient has Hematocrit between 30 and 52% and Platelet Count greater than 100,000/µl.
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.
PCI performed with unfractionated or low molecular weight heparin, or bivalirudin as the procedural antithrombin.

Key exclusion criteria (9 listed)

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:
Inability of the VerifyNow system to measure either Aspirin, P2Y12 or IIb/IIIa platelet responsiveness.
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.
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.
Patients in whom bypass graft surgery is planned within 2 years.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)Also: 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	Device	Observational

Primary outcome

Definite or probable stent thrombosis using the Academic Research Consortium (ARC) definition, primary events only.
Time frame: 30 days, 1 year, 2 year

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
Derived from this study: PubMed 36565189Shahim B, Redfors B, Stuckey TD, Liu M, Zhou Z, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Srdanovic I, Madhavan MV, Mazzaferri EL Jr, Mehran R, Ben-Yehuda O, Kirtane AJ, Stone GW. On-Treatment Platelet Reactivity and Ischemic Outcomes in Patients With Diabetes Mellitus: Two-Year Results From ADAPT-DES. J Am Heart Assoc. 2023 Jan 3;12(1):e026482. doi: 10.1161/JAHA.122.026482. Epub 2022 Dec 24.
Derived from this study: PubMed 35450679Redfors B, Kirtane AJ, Liu M, Musikantow DR, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Ben-Yehuda O, Mehran R, Stone GW. Dual Antiplatelet Therapy Discontinuation, Platelet Reactivity, and Adverse Outcomes After Successful Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2022 Apr 25;15(8):797-806. doi: 10.1016/j.jcin.2022.01.300.
Derived from this study: PubMed 31672031Gupta R, Kirtane AJ, Liu Y, Crowley A, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Mehran R, Ben-Yehuda O, Stone GW. Impact of Smoking on Platelet Reactivity and Clinical Outcomes After Percutaneous Coronary Intervention: Findings From the ADAPT-DES Study. Circ Cardiovasc Interv. 2019 Nov;12(11):e007982. doi: 10.1161/CIRCINTERVENTIONS.119.007982. Epub 2019 Nov 1.
Derived from this study: PubMed 30571206Maehara A, Mintz GS, Witzenbichler B, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri EL Jr, McAndrew T, Genereux P, Mehran R, Kirtane AJ, Stone GW. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents. Circ Cardiovasc Interv. 2018 Nov;11(11):e006243. doi: 10.1161/CIRCINTERVENTIONS.117.006243.
Derived from this study: PubMed 29908967Giustino G, Redfors B, Kirtane AJ, Mehran R, Dangas GD, Witzenbichler B, Neumann FJ, Weisz G, Genereux P, Maehara A, McAndrew T, Farhan S, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri EL Jr, Brodie BR, Stuckey TD, Gurbel P, Ben-Yehuda O, Stone GW. Platelet Reactivity and Risk of Ischemic Stroke After Coronary Drug-Eluting Stent Implantation: From the ADAPT-DES Study. JACC Cardiovasc Interv. 2018 Jul 9;11(13):1277-1286. doi: 10.1016/j.jcin.2018.01.263. Epub 2018 Jun 13.
Derived from this study: PubMed 29870382Redfors B, Genereux P, Witzenbichler B, Kirtane AJ, McAndrew T, Weisz G, Stuckey TD, Henry TD, Maehara A, Mehran R, Stone GW. Bleeding Severity After Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2018 Mar;11(3):e005542. doi: 10.1161/CIRCINTERVENTIONS.117.005542.
Derived from this study: PubMed 28495896Redfors B, Genereux P, Witzenbichler B, McAndrew T, Diamond J, Huang X, Maehara A, Weisz G, Mehran R, Kirtane AJ, Stone GW. Percutaneous Coronary Intervention of Saphenous Vein Graft. Circ Cardiovasc Interv. 2017 May;10(5):e004953. doi: 10.1161/CIRCINTERVENTIONS.117.004953.
Derived from this study: PubMed 28288963Gupta R, Kirtane AJ, Ozan MO, Witzenbichler B, Rinaldi MJ, Metzger DC, Weisz G, Stuckey TD, Brodie BR, Mehran R, Ben-Yehuda O, Stone GW. Platelet Reactivity and Clinical Outcomes After Coronary Artery Implantation of Drug-Eluting Stents in Subjects With Peripheral Arterial Disease: Analysis From the ADAPT-DES Study (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents). Circ Cardiovasc Interv. 2017 Mar;10(3):e004904. doi: 10.1161/CIRCINTERVENTIONS.116.004904.
Derived from this study: PubMed 28193677Yu J, Mehran R, Baber U, Ooi SY, Witzenbichler B, Weisz G, Rinaldi MJ, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Mazzaferri EL Jr, Brodie BR, Stuckey TD, Maehara A, Xu K, Ben-Yehuda O, Kirtane AJ, Stone GW. Sex Differences in the Clinical Impact of High Platelet Reactivity After Percutaneous Coronary Intervention With Drug-Eluting Stents: Results From the ADAPT-DES Study (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents). Circ Cardiovasc Interv. 2017 Feb;10(2):e003577. doi: 10.1161/CIRCINTERVENTIONS.116.003577.
Derived from this study: PubMed 28007741Wang B, Mintz GS, Witzenbichler B, Souza CF, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Matsumura M, Yamamoto MH, Parvataneni R, Kirtane AJ, Stone GW, Maehara A. Predictors and Long-Term Clinical Impact of Acute Stent Malapposition: An Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) Intravascular Ultrasound Substudy. J Am Heart Assoc. 2016 Dec 22;5(12):e004438. doi: 10.1161/JAHA.116.004438.
Derived from this study: PubMed 27402854Kobayashi N, Mintz GS, Witzenbichler B, Metzger DC, Rinaldi MJ, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Parvataneni R, Kirtane AJ, Stone GW, Maehara A. Prevalence, Features, and Prognostic Importance of Edge Dissection After Drug-Eluting Stent Implantation: An ADAPT-DES Intravascular Ultrasound Substudy. Circ Cardiovasc Interv. 2016 Jul;9(7):e003553. doi: 10.1161/CIRCINTERVENTIONS.115.003553.
Derived from this study: PubMed 26897675Yun KH, Mintz GS, Witzenbichler B, Inaba S, Shimizu T, Metzger DC, Rinaldi MJ, Mazzaferri EL Jr, Duffy PL, Weisz G, Stuckey TD, Brodie BR, Kirtane AJ, Stone GW, Maehara A. Relationship Between Platelet Reactivity and Culprit Lesion Morphology: An Assessment From the ADAPT-DES Intravascular Ultrasound Substudy. JACC Cardiovasc Imaging. 2016 Jul;9(7):849-854. doi: 10.1016/j.jcmg.2015.08.019. Epub 2016 Feb 17.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregg W. Stone, MD principal investigator

CardioVascular Research Foundation

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Cardiovascular Research Foundation, New York at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Definite or probable stent thrombosis using the Academic Research Consortium (ARC) definition, primary events only. (time frame: 30 days, 1 year, 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00638794, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.