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Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk: BAsel Stent Kosten Effektivitäts Trial - PROspective Validation Examination
ISRCTN ISRCTN72444640
DOI 10.1186/ISRCTN72444640
ClinicalTrials.gov identifier
EudraCT number
Public title Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk: BAsel Stent Kosten Effektivitäts Trial - PROspective Validation Examination
Scientific title
Acronym BASKET-PROVE
Serial number at source N/A
Study hypothesis The recent findings and analyses of the BAsel Stent Kosten Effektivitäts Trial (BASKET) and the Basel Stent Cost-effectiveness Trial - LAte Thrombotic Events trial (BASKET-LATE) are the basis for two relevant questions which will be addressed prospectively in BASKET-PROVE. The aims of BASKET-PROVE are therefore:
1. To validate findings of BASKET/BASKET-LATE, i.e. that patients with large native vessel stenting (more than or equal to 3.0 mm stents only) do not clinically benefit from Drug Eluting Stents (DES) regarding cardiac death/non-fatal Myocardial Infarction (MI) compared to a third generation Bare Metal Stent (BMS) over an 18 months observation period and may be associated even with a certain small late harm (i.e. comparison of Cypher-Select® versus Vision® stents)
2. To evaluate whether a stent with the same cobalt-chromium platform as Vision® but with a lower dose of a “limus” drug (Xience®, coated with Everolimus) has a similar late outcome as the third generation BMS Vision® stent (no increase in late cardiac death/MI)
Lay summary
Ethics approval Study approved by the local Ethics Committee (Ethikkommission beider Basel), on 11th January 2007 (ref: 327/06).
Study design Prospective randomised open-label muticentre trial
Countries of recruitment Denmark, Norway, Switzerland
Disease/condition/study domain Coronary artery disease
Participants - inclusion criteria 1. All comers, 24 hours a day, seven days a week, irrespective of indication for Percutaneous Coronary Intervention (PCI)
2. With the need for large (more than or equal to 3.0 mm stents only) native vessel stenting
Participants - exclusion criteria 1. In-stent-restenosis
2. Bypass graft disease
3. Main stem disease to be stented
4. Cardiogenic shock
5. Planned surgery within the next six months
6. Oral anticoagulation needed (artificial heart valves, atrial fibrillation)
7. No compliance expected
8. Enrolled in another study
9. No consent
Anticipated start date 01/02/2007
Anticipated end date 31/12/2010
Status of trial Completed
Patient information material
Target number of participants 2400
Interventions As of 20/05/2008: Participant recruitment has been completed on 16/05/2008. 2324 patients have been randomised.

Patients will be randomised to:
1. 1:1 to PCI and Stent placement with Cypher-Select® (standard first generation DES) versus Vision® (third generation cobalt-chromium BMS)
2. 1:1 to Xience® (DES with a lower dose of a “limus” drug, i.e. Everolimus [Abbott Vascular, Abbott Laboratories, Illinois, US]).
Primary outcome measure(s) Freedom of combination of:
1. Cardiac death (all death not clearly of extra cardiac origin)
2. Documented non-fatal MI (according to the current European Society of Cardiology [ESC]-guidelines after 24 months
Secondary outcome measure(s) 1. Non-MI related Target Vessel Revascularisation (TVR)
2. Major Adverse Cardiac Events (MACE) = primary outcomes and non-MI related TVR
3. Primary outcomes up to 18 and 36 months (for comparison with BASKET and BASKET-LATE)
4. Components of the primary outcomes
5. Non-cardiac death (total death)
6. Major non-Coronary Artery Bypass Graft (CABG) bleeding (need for surgery, blood transfusions, cerebral haemorrhages) during dual antiplatelet therapy (up to twelve months) - “net clinical benefit” = primary outcomes and bleeding
7. Subgroups with:
a. diabetes
b. acute coronary syndrome
c. ST-elevation MI
d. need for GlycoProtein (GP) IIb/IIIa inhibitors
e. lesions more than 25 mm
Sources of funding The Swiss National Foundation for Research (Switzerland) (study grant applied for)

Additional funding by unrestricted grants from third parties will be searched for.
Trial website
Publications
Contact name Prof  Mattias  Pfisterer
  Address Department of Cardiology
University Hospital
Petersgraben 4
  City/town Basel
  Zip/Postcode 4031
  Country Switzerland
  Email pfisterer@email.ch
Sponsor University Hospital Basel (Switzerland)
  Address Department of Cardiology
Petersgraben 4
  City/town Basel
  Zip/Postcode 4031
  Country Switzerland
  Email pfisterer@email.ch
  Sponsor website: http://www.universitaetsspital-basel.ch/
Date applied 18/01/2007
Last edited 11/08/2008
Date ISRCTN assigned 01/02/2007
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