NCT01166685

Brief Summary

Background: Retrospective analyses of long-term BASKET findings identified patients with large drug-eluting stents (DES) (\>2.5mm Stents) as patients at risk for late cardiac death/nonfatal myocardial infarction. In view of new DES with absorbable polymers and new bare metal stents BMS) with thin struts and biocompatible polymers, BP-II will be launched to test their comparative clinical safety up to 12 years if treated with an aspirin/prasugrel combination, since prasugrel halved stent thrombosis rates compared to clopidogrel in a large ACS trial. The primary objective is to demonstrate non-inferiority of the Nobori DES stent compared to the Xience Prime DES stent on safety and e cacy in patients requiring stents \>=3.0mm in diameter on the background of contemporary dual antiplatelet therapy (DAPT) with prasugrel and aspirin Set-up: Multicenter open-label randomized trial. Patient inclusion: Unselected series of patients in need of large (\>3mm) stents only in native vessels irrespective of clinical indication. Patient exclusion: In-stent restenosis, Left-main disease, cardiogenic shock, planned surgery \<12months, increased bleeding risk, no compliance expected, History of stroke or transient ischemic attack (TIA). Randomization: By centre using sealed envelopes 1:1:1: Nobori:Xience Prime:Prokinetik-stent.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,291

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Apr 2010

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 5, 2014

Status Verified

June 1, 2014

Enrollment Period

4.1 years

First QC Date

July 19, 2010

Last Update Submit

June 4, 2014

Conditions

Coronary Artery DiseaseCoronary Thrombosis

Keywords

coronary artery diseasedrug-eluting stentanti-thrombotic therapybare-metal stentlong-term outcome

Outcome Measures

Primary Outcomes (1)

  • MACE (composite endpoint including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR)

    2 years

Secondary Outcomes (8)

  • Cardiac death

    2 years

  • Myocardial infarction (MI)

    2 years

  • Target vessel revascularization (TVR)

    2 years

  • Composite safety endpoint of cardiac death and non-fatal MI

    2 years

  • Stent thrombosis according to ARC definitions

    2 years

  • +3 more secondary outcomes

Study Arms (3)

Everolimus-eluting stent

ACTIVE COMPARATOR

A Xience Prime stent (Everolimus-eluting stent) is implanted in significant coronary lesions.

Device: Everolimus-eluting stent

Bare-metal stent

ACTIVE COMPARATOR

Implantation of a bare-metal stent

Device: Bare-metal stent

Biodegradable Polymer-DES

EXPERIMENTAL

Implantation of a Biodegradable Polymer-DES

Device: Biodegradable Polymer-DES

Interventions

Everolimus-eluting stentDEVICE

Everolimus-eluting stent

Also known as: Xience-Prime stent
Everolimus-eluting stent
Bare-metal stentDEVICE

Bare metal stent

Also known as: ProKinetik
Bare-metal stent
Biodegradable Polymer-DESDEVICE

drug-eluting stent with bioabsorbable polymer

Also known as: Nobori stent
Biodegradable Polymer-DES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed concent
  • need for large (≥3.0 mm stents only) native vessel stenting

You may not qualify if:

  • in-Stent Restenosis or in-Stent Thrombosis
  • bypass graft disease to be stented
  • main stem disease to be stented
  • cardiogenic shock by clinical assessment (signs of organ hypoperfusion)
  • planned surgery within the next 12 months
  • oral anticoagulation needed (artificial heart valves,atrial fibrillation) or chronic haemorrhagic diathesis
  • active bleeding disorders
  • index-PCI = planned PCI of additional lesion
  • no follow-up (FU) expected/possible
  • History of stroke or TIA (contraindication for prasugrel)
  • known severe hypersensitivity reaction to ASS and/or Prasugrel
  • no compliance expected / no informed consent given
  • enrolled in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Universitätsklinikum

Innsbruck, 6020, Austria

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Elisabethen Krankenhaus

Essen, North Rhine-Westphalia, 45138, Germany

Location

Kantonsspital

Aarau, Canton of Aargau, 5000, Switzerland

Location

University Hospital

Basel, Canton of Basel-City, 4055, Switzerland

Location

Kantonsspital

Sankt Gallen, Canton of St. Gallen, Switzerland

Location

Stadtspital Triemli

Zurich, Canton of Zurich, 8063, Switzerland

Location

Cardiocentro

Lugano, Canton Ticino, 6903, Switzerland

Location

Related Publications (3)

  • Pfisterer M, Brunner-La Rocca HP, Rickenbacher P, Hunziker P, Mueller C, Nietlispach F, Leibundgut G, Bader F, Kaiser C; BASKET. Long-term benefit-risk balance of drug-eluting vs. bare-metal stents in daily practice: does stent diameter matter? Three-year follow-up of BASKET. Eur Heart J. 2009 Jan;30(1):16-24. Epub 2008 Nov 25. PMID: 19033260 Pfisterer M, Bertel O, Bonetti PO, Brunner-La Rocca HP, Eberli FR, Erne P, Galatius S, Hornig B, Kiowski W, Pachinger O, Pedrazzini G, Rickli H, De Servi S, Kaiser C; BASKET-PROVE Investigators. Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: study protocol and design. Am Heart J. 2008 Apr;155(4):609-14. Epub 2008 Feb 21. PMID: 18371466 Brunner-La Rocca HP, Kaiser C, Pfisterer M; BASKET Investigators. Targeted stent use in clinical practice based on evidence from the Basel Stent Cost Effectiveness Trial (BASKET). Eur Heart J. 2007 Mar;28(6):719-25. Epub 2007 Feb 13. PMID: 17298975

    BACKGROUND

  • Kaiser C, Galatius S, Jeger R, Gilgen N, Skov Jensen J, Naber C, Alber H, Wanitschek M, Eberli F, Kurz DJ, Pedrazzini G, Moccetti T, Rickli H, Weilenmann D, Vuillomenet A, Steiner M, Von Felten S, Vogt DR, Wadt Hansen K, Rickenbacher P, Conen D, Muller C, Buser P, Hoffmann A, Pfisterer M; BASKET-PROVE II study group. Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents: main results of the Basel Stent Kosten-Effektivitats Trial-PROspective Validation Examination II (BASKET-PROVE II), a randomized, controlled noninferiority 2-year outcome trial. Circulation. 2015 Jan 6;131(1):74-81. doi: 10.1161/CIRCULATIONAHA.114.013520. Epub 2014 Nov 19.

    PMID: 25411159DERIVED

  • Jeger R, Pfisterer M, Alber H, Eberli F, Galatius S, Naber C, Pedrazzini G, Rickli H, Jensen JS, Vuilliomenet A, Gilgen N, Kaiser C. Newest-generation drug-eluting and bare-metal stents combined with prasugrel-based antiplatelet therapy in large coronary arteries: the BAsel Stent Kosten Effektivitats Trial PROspective Validation Examination part II (BASKET-PROVE II) trial design. Am Heart J. 2012 Feb;163(2):136-41.e1. doi: 10.1016/j.ahj.2011.08.023.

    PMID: 22305828DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Thrombosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesThrombosisEmbolism and Thrombosis

Study Officials

  • Christoph A Kaiser, Prof. MD

    University Hospital Basel Cardiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2010

First Posted

July 21, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 5, 2014

Record last verified: 2014-06

Locations

DE(1)DK(1)CH(5)AU(1)