Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting

NCT ID: NCT00596570

Last Updated: 2010-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

996 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Oral Anticoagulation Percutaneous Coronary Intervention

Keywords

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Atrial fibrillation Oral Anticoagulation Percutaneous coronary intervention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patient with atrial fibrillation who underwent PCI

PCI

Intervention Type PROCEDURE

Percutaneous coronary interventiom

Interventions

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PCI

Percutaneous coronary interventiom

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with atrial fibrillation who undergo PCI.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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University of Turku

Principal Investigators

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Juhani KE Airaksinen, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Turku

Locations

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Juhani Airaksinen

Turku, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 24823675 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24481953 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23765437 (View on PubMed)

Other Identifiers

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12007

Identifier Type: -

Identifier Source: org_study_id