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Oral Anticoagulation clinical trials

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NCT ID: NCT04307225 Completed - Stroke Clinical Trials

Atrial Fibrillation After CABG and PCI

AFAF
Start date: August 2015
Phase:
Study type: Observational [Patient Registry]

Atrial fibrillation (AF) is the most common arrhythmia seen in clinical practice and is associated with an increased risk of stroke, heart failure and death. Oral anticoagulation (OAC) is the only treatment so far being able to reduce mortality in AF patients, despite new antiarrhythmic drugs and ablation techniques. Postoperative AF affects one-third of patients undergoing aortocoronary bypass surgery (CABG). Postoperative AF is associated with an increased 30-day mortality compared to patients who are in sinus rhythm during the hospital stay. . The risk of future AF is increased in patients with postoperative AF, and one-fourth of patients with an episode of postoperative AF develop later AF. At six years follow-up, 9.1% of patients with postoperative AF have had a lethal or non-lethal episode of ischemic stroke, compared to 3.0% of patients in SR (p=.002). Atrial fibrillation is a common complication of myocardial infarction, with an incidence of new-onset AF between 5-20%. New-onset AF occurs postoperatively in 5-6% of patients undergoing acute percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI), and is marker of adverse outcomes. However, studies of heart rhythm beyond the post procedural period following PCI are lacking. About one third of all AF is asymptomatic, silent and often paroxysmal. The risk of stroke seems to be the same for silent AF as for those with symptomatic AF. In trials comparing PCI and CABG, there is a consistent difference in stroke rate. Several studies have shown an increased risk of late cardiovascular death and ischemic stroke in postoperative AF patients, and the difference in stroke rate between PCI and CABG may be explained by unprotected episodes of AF after discharge. The investigators therefore hypothesize that patients undergoing CABG have an increased risk of silent AF postoperatively compared to patients undergoing PCI and that this difference may explain some of the differences in stroke rate between PCI and CABG patients.

NCT ID: NCT02533960 Completed - Clinical trials for Cardiovascular Diseases

Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

RASUNOA-Prime
Start date: June 2015
Phase:
Study type: Observational

The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an investigator-initiated study, is a German multicenter, prospective, observational registry. It is performed at about 50 certified stroke-units and supported by an unrestricted grant from different pharmaceutical companies to the Heidelberg University Hospital. RASUNOA-Prime is designed to assess the emergency management of acute ischemic and hemorrhagic stroke patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke: Non-vitamin K antagonist oral anticoagulants (NOAC), Vitamin K antagonists (VKA), and no anticoagulation.

NCT ID: NCT02067182 Completed - Atrial Fibrillation Clinical Trials

Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation

ODIn-AF
Start date: August 2015
Phase: Phase 4
Study type: Interventional

Oral anticoagulation treatment (OAC) following clinically successful catheter abla-tion of atrial fibrillation (AF) is controversial. Recent guidelines recommended con-tinuation of OAC in all patients with CHA2DS2VASc score ≥2 even if there is no evidence of recurrent AF (Camm JA et al., Eur Heart J 2012). The net clinical ben-efit of OAC after successful ablation in these patients remains to some extent un-clear. As OAC bears the risk of bleeding events, the ODIn-AF study aims to evalu-ate the positive effect of OAC on the incidence of silent cerebral embolic events in patients with a high risk for embolic events, free from AF after successful pulmo-nary vein ablation. ODIn-AF aims to determine that continued administration of dabigatran is superior in the preven-tion of silent cerebral embolism to discontinuation of OAC after 3 months in pa-tients free from symptomatic AF-episodes with a CHA2DS2VASc score ≥2 after the first pulmonary vein ablation for paroxysmal AF.

NCT ID: NCT01036646 Completed - Clinical trials for Oral Anticoagulation

User Performance Evaluation of the INRatio® Prothrombin Time (PT) Monitoring System With a New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity

ECLIPSE-02
Start date: August 2009
Phase: N/A
Study type: Observational

This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and 2) obtain accurate results for the quantitative determination of International Normalized Ratio (INR) when self-testing using fingerstick capillary blood. Patients will be trained by their healthcare provider using the instructions for use and product labeling provided. The accuracy of the patient INR results will be assessed by comparison to the INR results obtained by the site's trained healthcare professional using the same INRatio system (from a separate fingerstick collected from the same patient at the point-of-care), and with the INR results obtained on venous plasma obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560 System INR reference method.

NCT ID: NCT00603317 Completed - Atrial Fibrillation Clinical Trials

Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid

INWARA
Start date: March 2008
Phase: Phase 4
Study type: Interventional

Several case reports indicate that the use of the antibiotic combination amoxicillin and clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per se might also be responsible of these warfarin overdose reports, as well as the use of high dose paracetamol. The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics of warfarin among patients at steady state Double blinded cross over controlled study vs placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3 and a stable INR and a stable dose.

NCT ID: NCT00596570 Completed - Atrial Fibrillation Clinical Trials

Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting

AFCAS
Start date: January 2007
Phase: N/A
Study type: Observational

Treatment of patients suffering from atrial fibrillation pose problems when percutaneous coronary intervention with stent implantation (PCI-S) is performed. In the absence of solid evidence-based data, no definite recommendations for the management of this patient subset are currently given in the guidelines on percutaneous coronary intervention issued by the most prominent Cardiology Associations. The management of the antithrombotic treatment before invasive cardiac procedures is also incompletely defined. In this study we aim to determine in patients with atrial fibrillation undergoing PCI-S: 1. the contemporary antithrombotic management; 2. the relative safety and efficacy of the various post-PCI antithrombotic regimens; 3. the safety and efficacy of drug-eluting stents (DES), bare-metal stents (BMS), and bioactive stents (BAS); 4. the safety of various periprocedural antithrombotic strategies including glycoprotein IIb/IIIa inhibitors and bivalirudin; 5. safety and efficacy of radial vs femoral approach.