Plain English Summary

Not provided at time of registration

Trial website

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

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

http://www.universitaetsspital-basel.ch/

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

Publication citations

Editorial Notes