XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Total Occlusion of Coronary Artery, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis

In brief

XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are * To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and * To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.

Key facts

Study ID

NCT01106534

Run by

Abbott Medical Devices

People needed

870

Starts

2009-08-01

Expected to finish

2015-07-01

Last updated by the study team

2023-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are enrolled into the XIENCE V USA Study Phase I
• The patient agrees to participate in this study by signing the Institutional Review Board (IRB) approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form.

You may not qualify if…

• The inability to obtain an informed consent is an exclusion criterion.
• Patients must meet the following criteria to be eligible for randomization in the study:
• Patient is "12 Month Clear": "12-Month Clear" patients are free from death, MI, stroke, repeat coronary revascularization, major bleeding - "severe" or "moderate" by GUSTO classification, and ST 12 months after stent implantation. Staged PCI is allowed (same stent type as index); repeat PCI and peri-procedural myocardial infarction occurring with the index procedure or repeat procedure within the first 6 weeks will not be considered exclusionary events for the definition of "12 Month Clear".
• Patient is "DAPT Compliant": During the open label portion of this study (time 0-12 months), a patient is considered compliant with the thienopyridine therapy for the purposes of eligibility if they take between 80% and 120% of the prescribed drug in a given period without an interruption of therapy longer than 14 days. This information will be ascertained via data collected at the patient interviews at 6 and 12 months post-procedure. Compliance at both time points is required to be considered "clear".
• Patient completes 1 year visit within ± 30 days window.
• Patients will be excluded from randomization if any of the following criteria are met:
• Pregnant women.
• Switched thienopyridine type or dose within 6 months prior to randomization. Note: Thienopyridine switching during the open label portion of this study is discouraged.
• PCI or cardiac surgery between 6 weeks post index procedure and randomization.
• Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
• Current medical condition with a life expectancy of less than 3 years.
• Patients on warfarin or similar anticoagulant therapy.

Where it is running

• Thomas Hospital — Fairhope, Alabama, United States
• Scottsdale Healthcare — Scottsdale, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• California Cardiovascular Consultants — Fremont, California, United States
• FACT/ Los Angeles Cardiology — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• Eisenhower Medical Center, Desert Cardiology Center — Rancho Mirage, California, United States
• Regional Cardiology Associates — Sacramento, California, United States
• Salinas Valley Memorial Healthcare System — Salinas, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• The Medical Center of Aurora — Aurora, Colorado, United States
• St. Anthony's Central Hospital — Denver, Colorado, United States
• St. Vincent's Medical Center — Norwalk, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Brandon Regional Hospital — Brandon, Florida, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Sacred Heart Hospital — Pensacola, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Cardiology Partners Clinical Research Institute (Formerly Palm Beach Gardens Medical Center) — Wellington, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Saint Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
• University Hospital Augusta Cardiology Clinic — Augusta, Georgia, United States
• Birmingham Heart Clinic, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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