Safety and Efficacy Study Comparing 3 New Types of Coronary Stents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01166685
First received: July 19, 2010
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Coronary Thrombosis
Device: Everolimus-eluting stent
Device: Bare-metal stent
Device: Biodegradable Polymer-DES
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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 Part II (BASKET-PROVE II)

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • MACE (composite endpoint including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (MI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • Any MI
    • Non-fatal MI

  • Target vessel revascularization (TVR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    • Any TVR
    • Non-MI related TVR

  • Composite safety endpoint of cardiac death and non-fatal MI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis according to ARC definitions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • Definite
    • Definite or probable
    • Definite, probable or possible

  • Major bleeding including fatal bleeding, i.e., BARC >=3 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • All cause death [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Net clinical benefit = Primary endpoint plus major bleeding [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 2291
Study Start Date: April 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Everolimus-eluting stent
A Xience Prime stent (Everolimus-eluting stent) is implanted in significant coronary lesions.
Device: Everolimus-eluting stent
Everolimus-eluting stent
Other Name: Xience-Prime stent
Active Comparator: Bare-metal stent
Implantation of a bare-metal stent
Device: Bare-metal stent
Bare metal stent
Other Name: ProKinetik
Experimental: Biodegradable Polymer-DES
Implantation of a Biodegradable Polymer-DES
Device: Biodegradable Polymer-DES
drug-eluting stent with bioabsorbable polymer
Other Name: Nobori stent

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166685

Locations
Austria
Universitätsklinikum
Innsbruck, Austria, 6020
Denmark
Gentofte Hospital
Hellerup, Denmark, 2900
Germany
Elisabethen Krankenhaus
Essen, NRW, Germany, 45138
Switzerland
Kantonsspital
Aarau, AG, Switzerland, 5000
University Hospital
Basel, BS, Switzerland, 4055
Kantonsspital
St. Gallen, SG, Switzerland
Cardiocentro
Lugano, TI, Switzerland, 6903
Stadtspital Triemli
Zürich, ZH, Switzerland, 8063
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Chair: Christoph A Kaiser, Prof. MD University Hospital Basel Cardiology
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01166685     History of Changes
Obsolete Identifiers: NCT01097187
Other Study ID Numbers: BPII
Study First Received: July 19, 2010
Last Updated: June 4, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
coronary artery disease
drug-eluting stent
anti-thrombotic therapy
bare-metal stent
long-term outcome

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Thrombosis
Thrombosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 29, 2014