Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting (AFCAS)
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|ClinicalTrials.gov Identifier: NCT00596570|
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : June 30, 2010
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:
- the contemporary antithrombotic management;
- the relative safety and efficacy of the various post-PCI antithrombotic regimens;
- the safety and efficacy of drug-eluting stents (DES), bare-metal stents (BMS), and bioactive stents (BAS);
- the safety of various periprocedural antithrombotic strategies including glycoprotein IIb/IIIa inhibitors and bivalirudin;
- safety and efficacy of radial vs femoral approach.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Oral Anticoagulation Percutaneous Coronary Intervention||Procedure: PCI|
AFCAS study is an observational, multi-center, prospective registry including patients with atrial fibrillation undergoing PCI-S. Follow-up time is 12 months.
Primary end points are major hemorrhagic and thrombotic/thromboembolic complications including cardiac death and secondary endpoints are Major adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death), stent thrombosis and major/non major hemorrhagic complications. Clinical follow-up will be completed for all patients via telephone, or clinic visits scheduled at 1, 3, 6, and 12 months after PCI-S. The 1 and 6 months visits are optional. The patients will be asked about their clinical outcomes, hospitalizations and medications. Any additional information needed, such as specific mortality, will be obtained by contacting one of the patient's physicians or other health care professional or from death certificates. CRFs will be completed and faxed without delays after discharge, and after each follow up visit. Recruitment will take approximately 12 months. Follow-up will be 12 months for each patient.
|Study Type :||Observational|
|Actual Enrollment :||996 participants|
|Official Title:||Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting: A Multicenter, Prospective Registry|
|Study Start Date :||January 2007|
|Actual Study Completion Date :||February 2010|
Patient with atrial fibrillation who underwent PCI
Percutaneous coronary interventiom
- major hemorrhagic and thrombotic/thromboembolic complications including cardiac death [ Time Frame: one year ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596570
|Turku, Finland, 20520|
|Principal Investigator:||Juhani KE Airaksinen, Professor||University of Turku|