Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting

Atrial Fibrillation Clinical Trial

— AFCAS  

Official title:

Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting: A Multicenter, Prospective Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596570
• Other study ID #: 12007
• Status: Completed
• Phase: N/A
• First received: January 8, 2008
• Last updated: June 29, 2010
• Start date: January 2007
• Est. completion date: February 2010

Study information

• Verified date: December 2007
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 996
• Est. completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with atrial fibrillation who undergo PCI.

Exclusion Criteria:

• Because of the observational design, no exclusion criteria are provided.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Oral Anticoagulation
• Percutaneous Coronary Intervention

Intervention

Procedure:
• PCI
Percutaneous coronary interventiom

Locations

Country	Name	City	State
Finland	Juhani Airaksinen	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major hemorrhagic and thrombotic/thromboembolic complications including cardiac death		one year	No