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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

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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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