Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting (AFCAS)

• ClinicalTrials.gov Identifier: NCT00596570
• Recruitment Status: Completed
• First Posted: January 17, 2008
• Last Update Posted: June 30, 2010
• Sponsor: University of Turku
• Information provided by: University of Turku

Tracking Information

• First Submitted Date: January 8, 2008
• First Posted Date: January 17, 2008
• Last Update Posted Date: June 30, 2010
• Study Start Date: January 2007
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: January 8, 2008): major hemorrhagic and thrombotic/thromboembolic complications including cardiac death [ Time Frame: one year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief 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.

Detailed 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Anticoagulation samples

• Sampling Method: Probability Sample
• Study Population: Patients with atrial fibrillation undergoing PCI-S.

Condition

• Atrial Fibrillation
• Oral Anticoagulation
• Percutaneous Coronary Intervention

Intervention

Procedure: PCI

Percutaneous coronary interventiom

Study Groups/Cohorts

1

Patient with atrial fibrillation who underwent PCI

Intervention: Procedure: PCI

Publications *

• Puurunen M, Kiviniemi T, Nammas W, Schlitt A, Rubboli A, Nyman K, Karjalainen P, Kirchhof P, Lip GY, Airaksinen JK. Impact of anaemia on clinical outcome in patients with atrial fibrillation undergoing percutaneous coronary intervention: insights from the AFCAS registry. BMJ Open. 2014 May 13;4(5):e004700. doi: 10.1136/bmjopen-2013-004700.
• Rubboli A, Schlitt A, Kiviniemi T, Biancari F, Karjalainen PP, Valencia J, Laine M, Kirchhof P, Niemela M, Vikman S, Lip GY, Airaksinen KE; AFCAS Study Group. One-year outcome of patients with atrial fibrillation undergoing coronary artery stenting: an analysis of the AFCAS registry. Clin Cardiol. 2014 Jun;37(6):357-64. doi: 10.1002/clc.22254. Epub 2014 Jan 30.
• Schlitt A, Rubboli A, Lip GY, Lahtela H, Valencia J, Karjalainen PP, Weber M, Laine M, Kirchhof P, Niemela M, Vikman S, Buerke M, Airaksinen KE; AFCAS (Management of patients with Atrial Fibrillation undergoing Coronary Artery Stenting Study Group). The management of patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation: in-hospital-data from the Atrial Fibrillation undergoing Coronary Artery Stenting study. Catheter Cardiovasc Interv. 2013 Dec 1;82(7):E864-70. doi: 10.1002/ccd.25064. Epub 2013 Aug 28.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 29, 2010): 996
• Original Estimated Enrollment (submitted: January 8, 2008): 1000
• Actual Study Completion Date: February 2010
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Patients with atrial fibrillation who undergo PCI.

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT00596570
• Other Study ID Numbers: 12007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Juhani Airaksinen, University of Turku
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Turku
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Juhani KE Airaksinen, Professor; University of Turku

• PRS Account: University of Turku
• Verification Date: December 2007