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Stent Thrombosis clinical trials

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NCT ID: NCT02617290 Completed - Clinical trials for Coronary Artery Disease

Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting

ALPHEUS
Start date: January 9, 2017
Phase: Phase 3
Study type: Interventional

The new P2Y12 inhibitors prasugrel (Efient®-Effient®) and ticagrelor (Brilique®-Brilinta®) have shown promising results in the respective TRITON and PLATO trials making of prasugrel and ticagrelor recommended first line treatments for acute coronary syndrome ACS (ESC Guidelines: Class 1 LOE B). These two drugs showed superiority over clopidogrel in ACS patients undergoing percutaneous coronary intervention (PCI), by the dramatic diminution of stent thrombosis, the reduction in death or Myocardial Infarction (MI) as well as the reduction in death in a meta-analysis. The field of elective PCI (stable patients) has not been studied with these 2 new drugs and clopidogrel remains the standard of care. However, off-label use of prasugrel and ticagrelor is increasing in patients undergoing high risk elective PCI (left main, diabetics, multiple stenting, high risk of stent thrombosis, no clopidogrel pretreatment…) but is not supported by scientific evidence. More than half of PCI patients undergo elective stenting for proven ischemia and/or stable angina, a relatively safe procedure with the use of the latest generation of stents. However complications remain either frequent when considering PCI-related myonecrosis/myocardial injury that have been linked to the prognosis of patients or rare but serious when considering stent thrombosis, Q wave MI or stroke, leaving room for improvement with these two newest drugs. The investigators propose to perform a multicenter international study in stable patients undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The investigators hypothesize that this study will show superiority of the new P2Y12 inhibitor over clopidogrel in elective PCI on the primary ischemic endpoint (peri-procedural MI and myocardial injury) without significant excess bleeding (BARC definition).

NCT ID: NCT01894152 Completed - Clinical trials for Coronary Artery Disease

XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study

XP China SAS
Start date: July 2013
Phase:
Study type: Observational

Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011. This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China. This study has no primary outcome measure. All observations are of equal weight.

NCT ID: NCT01410539 Completed - Stent Thrombosis Clinical Trials

Mechanism Of Stent Thrombosis (MOST) Study

Most
Start date: January 2010
Phase: Phase 4
Study type: Interventional

This study is designed to assess the pathophysiology of ST by studying the main procedural and anatomical factors involved in the genesis of ST such as those related to stent and the vascular wall, as well as to the individual platelet residual reactivity.

NCT ID: NCT01249027 Completed - Clinical trials for Coronary Artery Disease

XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study

XV CHINA SAS
Start date: November 2010
Phase:
Study type: Observational

This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to: - Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use - Evaluate patient compliance to dual antiplatelet therapy (DAPT)

NCT ID: NCT01231035 Completed - Stent Thrombosis Clinical Trials

REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary Syndromes (RECLOSE 2 - ACS)

RECLOSE2-ACS
Start date: September 2008
Phase: N/A
Study type: Observational

The main objective of the project is to assess the long-term prognostic impact of residual platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with acute coronary syndrome undergoing invasive strategy. Follow-up length will be at least 24 months. The primary end-point of the study will be a composite of death, myocardial infarction, urgent target vessel revascularization, stent thrombosis or stroke.

NCT ID: NCT01205789 Completed - Clinical trials for Coronary Artery Disease

EXCEL Clinical Trial (Universal Registry)

EXCEL
Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns.

NCT ID: NCT01205776 Completed - Clinical trials for Coronary Artery Disease

EXCEL Clinical Trial

EXCEL
Start date: September 29, 2010
Phase: N/A
Study type: Interventional

To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.

NCT ID: NCT01182428 Completed - Clinical trials for Coronary Artery Disease

XIENCE V: SPIRIT WOMEN Sub-study

Start date: September 2008
Phase: Phase 4
Study type: Interventional

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIMEâ„¢ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

NCT ID: NCT01086228 Completed - Clinical trials for Coronary Artery Disease

XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan

Start date: March 2010
Phase: N/A
Study type: Observational

The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.

NCT ID: NCT00998127 Completed - Stent Thrombosis Clinical Trials

Patterns of Non-Adherence to Dual Anti-Platelet Regimen In Stented Patients

PARIS
Start date: June 2009
Phase: N/A
Study type: Observational

The purpose of this observational research study is to determine when and why patients discontinue, interrupt, or disrupt the regimen of anti-platelet medications prescribed following stent implantation, and to examine the relationship between specific patterns of non-adherence and patient outcomes.