Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk
| ISRCTN | ISRCTN72444640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72444640 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/01/2007
- Registration date
- 01/02/2007
- Last edited
- 17/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Mattias Pfisterer
Scientific
Scientific
Department of Cardiology
University Hospital
Petersgraben 4
Basel
4031
Switzerland
| pfisterer@email.ch |
Study information
| Study design | Prospective randomised open-label muticentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | BASKET-PROVE |
| Study objectives | 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(s) | Local Ethics Committee (Ethikkommission beider Basel), 11/01/2007, ref: 327/06 |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | 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 |
| Primary outcome measure | 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 study start date | 01/02/2007 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 2400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 16/05/2008 |
Locations
Countries of recruitment
- Denmark
- Norway
- Switzerland
Study participating centre
University Hospital Basel
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Department of Cardiology
Petersgraben 4
Basel
4031
Switzerland
| pfisterer@email.ch | |
| Website | http://www.universitaetsspital-basel.ch/ |
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Government
The Swiss National Foundation for Research (Switzerland) (study grant applied for)
No information available
Additional funding by unrestricted grants from third parties will be searched for.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/10/2013 | Yes | No | |
| Results article | results | 01/10/2015 | Yes | No |
