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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00596570
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : June 30, 2010
Sponsor:
Information provided by:
University of Turku

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Oral Anticoagulation Percutaneous Coronary Intervention Procedure: PCI

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.

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Study Type : Observational
Actual Enrollment : 996 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1
Patient with atrial fibrillation who underwent PCI
Procedure: PCI
Percutaneous coronary interventiom




Primary Outcome Measures :
  1. major hemorrhagic and thrombotic/thromboembolic complications including cardiac death [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
Anticoagulation samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with atrial fibrillation undergoing PCI-S.
Criteria

Inclusion Criteria:

  • Patients with atrial fibrillation who undergo PCI.

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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Finland
Juhani Airaksinen
Turku, Finland, 20520
Sponsors and Collaborators
University of Turku
Investigators
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Principal Investigator: Juhani KE Airaksinen, Professor University of Turku
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juhani Airaksinen, University of Turku
ClinicalTrials.gov Identifier: NCT00596570    
Other Study ID Numbers: 12007
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: December 2007
Keywords provided by University of Turku:
Atrial fibrillation
Oral Anticoagulation
Percutaneous coronary intervention
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes