Ongoing WARfarin and Coronary STENTing

Atrial Fibrillation Clinical Trial

— WAR-STENT  

Official title:

Ongoing WARfarin and Coronary STENTing. A Multi-center, Prospective Registry on Antithrombotic Treatment.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00722319
• Other study ID #: WS-1
• Status: Active, not recruiting
• Phase: N/A
• First received: July 23, 2008
• Last updated: August 11, 2011
• Start date: March 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2010
• Source: War-Stent Investigators
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Patients on warfarin treatment pose particular problems when undergoing percutaneous coronary intervention with stent implantation (PCI-S), because of the poor definition of the optimal antithrombotic strategies to be adopted both peri-procedurally and during the 4 (or more) weeks after PCI-S, when dual antiplatelet therapy with aspirin and clopidogrel is recommended. 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. Indeed, a high variability has been reported in the current antithrombotic strategies, which may consist in either the temporary substitution of warfarin by dual antiplatelet treatment or the combination of warfarin and aspirin or clopidogrel or both. Peri-procedural bridging therapy with either intravenous unfractionated or subcutaneous low-molecular-weight heparin is also variably carried out. Purpose of this registry is to determine in patients on warfarin treatment undergoing PCI-S: 1) the contemporary peri-procedural and medium-term antithrombotic management; and 2) the relative safety and efficacy of the various antithrombotic regimens.

Description:

Patients on oral anticoagulation with vitamin-K antagonists who undergo PCI-S will be prospectively included in the registry and follow up for 12 months

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: October 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with ongoing warfarin treatment.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atrial Fibrillation

Locations

Country	Name	City	State
Italy	Division of Cardiology	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
War-Stent Investigators

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Rubboli A, Colletta M, Di Pasquale G. Regarding antithrombotic treatment after coronary stenting in patients on chronic oral anticoagulation. Am Heart J. 2005 Feb;149(2):E1. — View Citation

Rubboli A, Colletta M, Herzfeld J, Sangiorgio P, Di Pasquale G. Periprocedural and medium-term antithrombotic strategies in patients with an indication for long-term anticoagulation undergoing coronary angiography and intervention. Coron Artery Dis. 2007 May;18(3):193-9. — View Citation

Rubboli A, Di Pasquale G. The combination of anticoagulant and anti-platelet therapy in patients with atrial fibrillation: a comment on the recent ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. Eur Heart J. 2006 Dec;27(23):2908-9; author reply 2909-10. Epub 2006 Oct 30. — View Citation

Rubboli A, Halperin JL, Airaksinen KE, Buerke M, Eeckhout E, Freedman SB, Gershlick AH, Schlitt A, Tse HF, Verheugt FW, Lip GY. Antithrombotic therapy in patients treated with oral anticoagulation undergoing coronary artery stenting. An expert consensus document with focus on atrial fibrillation. Ann Med. 2008;40(6):428-36. doi: 10.1080/07853890802089786. Review. — View Citation

Rubboli A, Milandri M, Castelvetri C, Cosmi B. Meta-analysis of trials comparing oral anticoagulation and aspirin versus dual antiplatelet therapy after coronary stenting. Clues for the management of patients with an indication for long-term anticoagulation undergoing coronary stenting. Cardiology. 2005;104(2):101-6. Epub 2005 Jul 12. — View Citation

Rubboli A, Verheugt FW. Antithrombotic treatment for patients on oral anticoagulation undergoing coronary stenting: a review of the available evidence and practical suggestions for the clinician. Int J Cardiol. 2008 Jan 24;123(3):234-9. Epub 2007 Apr 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major/minor bleeding + adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death) + arterial/venous thrombosis/thromboembolism		1, 3, 6 and 12 months	Yes
Secondary	Incidence of major/minor bleeding		1, 3, 6 and 12 months	Yes
Secondary	Adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death)		1, 3, 6 and 12 months	Yes
Secondary	Stent thrombosis		1, 3, 6 and 12 months	Yes
Secondary	Arterial/venous thromboembolism;		1, 3, 6 and 12 months	Yes
Secondary	Blood transfusions		1, 3, 6 and 12 months	Yes