Track topics on Twitter Track topics that are important to you
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.
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Chronic Coronary Occlusion
Thienopyridine (clopidogrel or prasugrel)
Birmingham Heart Clinic, PC
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:14:28-0400
- The purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the ...
Clopidogrel administration is essential in patients undergoing percutaneous coronary intervention, in patients with previous stroke, in patients under chronic hemodialysis via fistulae and...
This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study ...
This study will evaluate the use of a prasugrel 60 mg loading dose administered during percutaneous coronary intervention (PCI) with and without a prior loading dose (LD)of clopidogrel on ...
This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) o...
Prasugrel is a thienopyridine that inhibits platelet aggregation more rapidly and effectively than clopidogrel, with an increased bleeding risk.
In the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial of patients with non-ST-segment elevation acute coronary syndrome m...
Dual antiplatelet therapy (DAPT) is the treatment of choice in the medical management of patients with acute coronary syndrome (ACS). The combination of aspirin and a P2Y12 inhibitor in patients who r...
Prasugrel and clopidogrel are inhibitors of the ADP-PYplatelet receptor used in acute coronary syndrome patients. They require bioactivation via isoenzymes such as cytochrome P450 (CYP) 3A4, CYP2C19 ...
Patients with diabetes mellitus (DM) and acute coronary syndromes have a greater level of platelet aggregation and a poor response to oral antiplatelet drugs. Clopidogrel is still widely used in clini...
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.
A family of percutaneous techniques that are used to manage CORONARY OCCLUSION, including standard balloon angioplasty (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY), the placement of intracoronary STENTS, and atheroablative technologies (e.g., ATHERECTOMY; ENDARTERECTOMY; THROMBECTOMY; PERCUTANEOUS TRANSLUMINAL LASER ANGIOPLASTY). PTCA was the dominant form of PCI, before the widespread use of stenting.
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.
Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...
A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body. A stent is placed in an artery as part of a procedure called angioplasty. &...