Contact information
Type
Scientific
Primary contact
Prof Mattias Pfisterer
ORCID ID
Contact details
Department of Cardiology
University Hospital
Petersgraben 4
Basel
4031
Switzerland
-
pfisterer@email.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific 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
Acronym
BASKET-PROVE
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)
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Coronary artery disease
Intervention
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]).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/02/2007
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
2400
Participant 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
Recruitment start date
01/02/2007
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Denmark, Norway, Switzerland
Trial participating centre
Department of Cardiology
Basel
4031
Switzerland
Sponsor information
Organisation
University Hospital Basel (Switzerland)
Sponsor details
Department of Cardiology
Petersgraben 4
Basel
4031
Switzerland
-
pfisterer@email.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
The Swiss National Foundation for Research (Switzerland) (study grant applied for)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Additional funding by unrestricted grants from third parties will be searched for.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23453439