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Acute Coronary SyndromeWAR-STENTNCT00722319

Ongoing WARfarin and Coronary STENTing

An observational study of Acute Coronary Syndrome and Atrial Fibrillation, run by War-Stent Investigators at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Coronary Syndrome, Atrial Fibrillation
Type of treatment
Pill or oral medicine
How many people
1,000 participants
Where
1 siteItaly
Study dates
Mar 2009to Oct 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients treated with warfarin who are hospitalized at tertiary centers all over the country to undergo percutaneous coronary intervention with stent implantation

Who may be able to join

  • Patients with ongoing warfarin treatment.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Division of Cardiology

    Bologna, 40133

Other trials in Italy

About this study

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

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.

Read the detailed 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

Keywords
oral anticoagulation, warfarin, percutaneous coronary intervention, stent, antiplatelet agents
Medical subject headings
Acute Coronary Syndrome, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00722319
Study groupRoleWhat they receive
APatients on long-term oral anticoagulation who are submitted to PCI-S because of acute coronary syndrome or stable angina. No further groups nor interventions are anticipated since the study is observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of major/minor bleeding + adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death) + arterial/venous thrombosis/thromboembolism

    Measured: 1, 3, 6 and 12 months

Secondary outcomes (5)

  1. Incidence of major/minor bleeding

    Measured: 1, 3, 6 and 12 months

  2. Adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death)

    Measured: 1, 3, 6 and 12 months

  3. Stent thrombosis

    Measured: 1, 3, 6 and 12 months

  4. Arterial/venous thromboembolism;

    Measured: 1, 3, 6 and 12 months

  5. Blood transfusions

    Measured: 1, 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2008 (estimated)
  2. Study startMar 2009
  3. Primary completionJul 2010
  4. Study completionOct 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00722319
Sponsor's protocol ID
WS-1
Acronym
WAR-STENT
Status last verified
Jan 2010
First submitted
23 Jul 2008
Last updated
12 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18608125

  • 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. doi: 10.1016/j.ijcard.2007.02.017. Epub 2007 Apr 16.

    PubMed 17434621

  • 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. doi: 10.1097/MCA.0b013e328012a964.

    PubMed 17429293

  • 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. doi: 10.1093/eurheartj/ehl348. Epub 2006 Oct 30. No abstract available.

    PubMed 17074773

  • 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. doi: 10.1159/000086918. Epub 2005 Jul 12.

    PubMed 16020950

  • 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. doi: 10.1016/j.ahj.2004.08.019. No abstract available.

    PubMed 15846242

  • Rubboli A, Saia F, Sciahbasi A, Leone AM, Palmieri C, Bacchi-Reggiani ML, Calabro P, Bordoni B, Piccalo G, Franco N, Nicolino A, Magnavacchi P, Vignali L, Mameli S, Dallago M, Maggiolini S, Steffanon L, Piovaccari G, Di Pasquale G; WARfarin and Coronary STENTing (WAR-STENT) Study group. Twelve-month outcome of patients with an established indication for oral anticoagulation undergoing coronary artery stenting and stratified by the baseline risk of bleeding: Insights from the Warfarin and Coronary Stenting (War-Stent) Registry. Cardiovasc Revasc Med. 2017 Sep;18(6):425-430. doi: 10.1016/j.carrev.2017.03.015. Epub 2017 Mar 19.

    PubMed 28363682

  • Rubboli A, Saia F, Sciahbasi A, Bacchi-Reggiani ML, Steffanon L, Briguori C, Calabro P, Palmieri C, Rizzi A, Imperadore F, Sangiorgi GM, Valgimigli M, Carosio G, Steffenino G, Galvani M, Di Pasquale G, La Vecchia L, Maggioni AP, Bolognese L; WARfarin and Coronary STENTing (WAR-STENT) Study Group. Outcome of patients on oral anticoagulation undergoing coronary artery stenting: data from discharge to 12 months in the Warfarin and Coronary Stenting (WAR-STENT) Registry. J Invasive Cardiol. 2014 Nov;26(11):563-9.

    PubMed 25363997

  • Rubboli A, Sciahbasi A, Briguori C, Saia F, Palmieri C, Moroni LA, Calabro P, Leone AM, Franco N, Valgimigli M, Varani E, Santi M, Pasqualini P, Capecchi A, Piccalo G, Margheri M, di Pasquale G, Galvani M, Bolognese L, Gonzini L, Maggioni AP; WARfarin and coronary STENTing registry. In-hospital management and outcome of patients on warfarin undergoing coronary stent implantation: results of the multicenter, prospective WARfarin and coronary STENTing (WAR-STENT) registry. J Invasive Cardiol. 2013 Apr;25(4):170-6.

    PubMed 23549489

  • Rubboli A, Bolognese L, Di Pasquale G, Galvani M, La Vecchia L, Maggioni AP. A prospective multicentre observational study on the management of patients on oral anticoagulation undergoing coronary artery stenting: rationale and design of the ongoing warfarin and coronary stenting (WAR-STENT) registry. J Cardiovasc Med (Hagerstown). 2009 Feb;10(2):200-3. doi: 10.2459/JCM.0b013e3283212f07.

    PubMed 19377385

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Atrial Fibrillation, run by War-Stent Investigators at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00722319, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2011.

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Ongoing WARfarin and Coronary STENTing (NCT00722319) | AzTrials