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XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort

2014-08-27 03:14:28 | BioPortfolio

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.

Description

Among patients enrolled in the XIENCE V USA who have completed Study Phase I, some will be eligible to participate in the XIENCE V USA AV DAPT Cohort. This prospective, multi-center, randomized, double-blind AV-DAPT study cohort is designed to collect data to support the FDA DAPT initiative. The protocol for AV-DAPT cohort is designed according to the HCRI-DAPT study protocol, Study IDE # G080186. Up to 1,524 patients from the additional 3,000 patients treated with XIENCE V who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - "severe" or "moderate" by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the cohort. Patients who are considered as part of the AV-DAPT cohort will be randomized to either their DAPT or placebo for an additional 18-month thienopyridine treatment (from 12 months to 30 months) at 12 months post index procedure. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular. The patients who are eligible for the AV-DAPT cohort but can not participate in the AV-DAPT cohort because the cap of 1,524 is reached will be identified for HCRI to participate in the HCRI-DAPT cohort. The remaining patients from the additional 3,000 patients who do not participate in AVDAPT cohort or HCRI-DAPT cohort will be followed for the first year only.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Chronic Coronary Occlusion

Intervention

Thienopyridine (clopidogrel or prasugrel)

Location

Birmingham Heart Clinic, PC
Birmingham
Alabama
United States
35235

Status

Active, not recruiting

Source

Abbott Vascular

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:28-0400

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Medical and Biotech [MESH] Definitions

A piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.

Complete blockage of blood flow through one of the CORONARY ARTERIES, usually from CORONARY ATHEROSCLEROSIS.

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A complication of INTERNAL MAMMARY-CORONARY ARTERY ANASTOMOSIS whereby an occlusion or stenosis of the proximal SUBCLAVIAN ARTERY causes a reversal of the blood flow away from the CORONARY CIRCULATION, through the grafted INTERNAL MAMMARY ARTERY (internal thoracic artery), and back to the distal subclavian distribution.

Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.

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