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...
Date First Received: July 23, 2008
Last Updated: February 17, 2009
Verified by: War-Stent Investigators, January 2009
Clinical Trial Phase: N/A | Start Date: March 2009
Overall Status: Not yet recruiting
Estimated Enrollment: 1000
Brief Summary
Official Title: “Ongoing WARfarin and Coronary STENTing. A Multi-Center, Prospective Registry on Antithrombotic Treatment.”
Condition Keyword(s):
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.
Study Type: Observational
Study Design: Cohort, Prospective
Study Primary Completion Date: October 2009
Arms, Groups and Cohorts in this Clinical Trial
- : A
- Patients on warfarin undergoing percutaneous coronary intervention with stent implantation.
Outcome Measures for this Clinical Trial
Primary Measures
- Incidence of major/minor bleeding + adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death) + arterial/venous
thrombosis/thromboembolism
- Time Frame: 1, 3, 6 and 12 months
Safety Issue?: Yes
- Time Frame: 1, 3, 6 and 12 months
Secondary Measures
- Incidence of major/minor bleeding
- Time Frame: 1, 3, 6 and 12 months
Safety Issue?: Yes
- Time Frame: 1, 3, 6 and 12 months
- Adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death)
- Time Frame: 1, 3, 6 and 12 months
Safety Issue?: Yes
- Time Frame: 1, 3, 6 and 12 months
- Stent thrombosis
- Time Frame: 1, 3, 6 and 12 months
Safety Issue?: Yes
- Time Frame: 1, 3, 6 and 12 months
- Arterial/venous thromboembolism;
- Time Frame: 1, 3, 6 and 12 months
Safety Issue?: Yes
- Time Frame: 1, 3, 6 and 12 months
- Blood transfusions
- Time Frame: 1, 3, 6 and 12 months
Safety Issue?: Yes
- Time Frame: 1, 3, 6 and 12 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients with ongoing warfarin treatment.
Exclusion Criteria:
- None
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: War-Stent Investigators
Overall Clinical Trial Officials and Contacts
Andrea Rubboli, MD Study Director Division of Cardiology, Maggiore Hospital, Bologna
Overall Contact: Andrea Rubboli, MD +390516478111 andrearubboli@libero.it
Related Publications
References
Rubboli A, Halperin JL, Juhani Airaksinen KE, Buerke M, Eeckhout E, Freedman SB, Gershlick AH, Schlitt A, Fat Tse H, 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 May 2;:1-9 [Epub ahead of print]
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.
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.
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. No abstract available.
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.
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. No abstract available.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00722319
Study ID Number: WS-1
ClinicalTrials.gov Identifier: NCT00722319
Health Authority: Italy: Ethics Committee
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
