XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott Medical Devices; Abbott Vascular
• Collaborators: Baim Institute for Clinical Research; Bristol-Myers Squibb; Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.; Eli Lilly and Company; Harvard Clinical Research Institute
• Treatments: Aspirin; Clopidogrel; Everolimus; Prasugrel Hydrochloride; Sirolimus

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.