NCT01385319

Brief Summary

To prospectively evaluate in a multicenter open label trial whether the use of zotarolimus-eluting ENDEAVOR Stent implantation in patients at low restenosis or at high bleeding or thrombotic risk will decrease the incidence of 12-month major adverse cardiac events (MACE) including overall death, any myocardial infarction (MI) or any target vessel revascularization (TVR).

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,606

participants targeted

Target at P75+ for phase_3 coronary-artery-disease

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_3 coronary-artery-disease

Geographic Reach
4 countries

16 active sites

Status
unknown

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

June 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

June 24, 2011

Last Update Submit

October 6, 2012

Conditions

Coronary Artery Disease

Keywords

Bare metal stentzotarolimus eluting stenttriple anti-thrombotic therapyhigh bleeding riskduration of dual anti-platelet therapy

Outcome Measures

Primary Outcomes (1)

  • MACE

    Major adverse cardiovascular events including death for any cause, non-fatal myocardial infarction or target vessel revascularisation

    12 months

Secondary Outcomes (4)

  • Death

    12 months

  • myocardial infarction

    12 months

  • TVR

    12 months

  • stent thrombosis

    12 months

Study Arms (2)

bare metal stent

ACTIVE COMPARATOR
Device: Bare metal stent implantation

Endeavor sprint stent

EXPERIMENTAL
Device: zotarolimus eluting stent

Interventions

Bare metal stent implantationDEVICE

After BMS implantation the duration of dual anti-platelet therapy is a function of the clinical presentation and the bleeding risk a given patient as follows: Clopidogrel will be given for 1 month after PCI if indication to the procedure is stable coronary artery disease or for at least 6 month if indication to the procedure is ACS, including STEMI or NSTEACS. At discretion of the treating physician, prasugrel or ticagrelor may replace clopidogrel in ACS patients. Patients recruited in the study due to high bleeding risk will receive clopidogrel for at least 30 days. Patients recruited in the study due to high thrombosis risk will receive clopidogrel monotherapy life long or DAPT for at least 1 month.

bare metal stent
zotarolimus eluting stentDEVICE

After ZES implantation the duration of dual anti-platelet therapy is a function of the clinical presentation and the bleeding risk a given patient (i.e. identical to criteria set out for BMS patients) as follows: Clopidogrel will be given for 1 month after PCI if indication to the procedure is stable coronary artery disease or for at least 6 month if indication to the procedure is ACS, including STEMI or NSTEACS. At discretion of the treating physician, prasugrel or ticagrelor may replace clopidogrel in ACS patients. Patients recruited in the study due to high bleeding risk will receive clopidogrel for at least 30 days. Patients recruited in the study due to high thrombosis risk will receive clopidogrel monotherapy life long or DAPT for at least 1 month.

Endeavor sprint stent

Eligibility Criteria

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

You may qualify if:

  • A) low restenosis risk based on angiographic findings defined as follows:
  • patients will be considered at low restenosis risk if no planned stent lower than 3.0 mm is intended to be implanted in lesions expect left main or vein graft
  • B) high bleeding risk and/or presence of relative-absolute contraindication to dual anti-platelet treatment beyond 30 days defined as follows:
  • Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
  • Recent (within previous 12 months) bleeding episode(s) which required medical attention
  • Previous bleeding episode(s) which required hospitalization if the bleeding diathesis has not been completely resolved (i.e. surgical removal of the bleeding source)
  • Age greater than 80
  • Systemic conditions associated to increased bleeding risk (e.g. hematological disorders or any known coagulopathy determining bleeding diathesis, including history of or current thrombocytopenia defined as platelet count \<100,000/mm3 (\<100 x 109/L).
  • Known Anemia defined as repeatedly documented hemoglobin lower than 10 gr/dl which is not due to an acute and documented blood loss
  • Need for chronic treatment with steroids or NSAID
  • C) Patients at high thrombosis risk based on the presence of at least one of the following criteria:
  • Allergy/intolerance to aspirin
  • Allergy/intolerance to clopidogrel AND ticlopidine
  • Planned surgery (other than skin) within 12 months of percutaneous coronary intervention (PCI).
  • patient with cancers (other than skin) and life expectancy \>1 year
  • +1 more criteria

You may not qualify if:

  • Any of the following:
  • Women who are pregnant. Women of childbearing potential must have a negative pregnancy test (urine or serum HCG) within 7 days prior to randomization; as close to randomization as possible, within 24 hours preferred.
  • Subjects who are unable to give informed consent and assurance for complete contact through 12 months.
  • PCI with stenting in the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Albert Szent-Györgyi Clinical Center, University of Szeged

Szeged, Hungary

Location

Ospedale San Donato

Arezzo, AR, 52100, Italy

Location

Ospedali Riuniti di Bergamo

Bergamo, BG, 24128, Italy

Location

Policlinico San Marco

Zingonia, BG, 24040, Italy

Location

Ospedale di Savigliano

Savigliano, CN, 12038, Italy

Location

Istituto Clinico Sant'Ambrogio

Milan, MI, 20149, Italy

Location

Azienda Unita' Sanitaria Locale Di Modena - Ospedale Baggiovara

Modena, MO, 41100, Italy

Location

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, 43126, Italy

Location

Policlinico San Matteo

Pavia, PV, 27100, Italy

Location

Ospedale di Ravenna

Ravenna, RA, 48121, Italy

Location

Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I

Torino, TO, 10128, Italy

Location

Ospedale San Giovanni Bosco

Torino, TO, 10154, Italy

Location

University Hospital of Ferrara

Ferrara, 44100, Italy

Location

Clinica Mediterranea

Naples, 80122, Italy

Location

Hospital de Santa Cruz

Carnaxide, Portugal

Location

University Hospital of Geneva

Geneva, Switzerland

Location

Related Publications (3)

  • Ariotti S, Adamo M, Costa F, Patialiakas A, Briguori C, Thury A, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Ferlini M, Vranckx P, Valgimigli M; ZEUS Investigators. Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial. JACC Cardiovasc Interv. 2016 Mar 14;9(5):426-36. doi: 10.1016/j.jcin.2015.11.015.

    PMID: 26965932DERIVED

  • Valgimigli M, Patialiakas A, Thury A, McFadden E, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Airoldi F, Ferlini M, Liistro F, Dellavalle A, Vranckx P, Briguori C; ZEUS Investigators. Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. J Am Coll Cardiol. 2015 Mar 3;65(8):805-815. doi: 10.1016/j.jacc.2014.11.053.

    PMID: 25720624DERIVED

  • Valgimigli M, Patialiakas A, Thury A, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Airoldi F, Ferlini M, Liistro F, Dellavalle A, Vranckx P, Briguori C. Randomized comparison of Zotarolimus-Eluting Endeavor Sprint versus bare-metal stent implantation in uncertain drug-eluting stent candidates: rationale, design, and characterization of the patient population for the Zotarolimus-eluting Endeavor Sprint stent in uncertain DES candidates study. Am Heart J. 2013 Nov;166(5):831-8. doi: 10.1016/j.ahj.2013.07.033. Epub 2013 Sep 26.

    PMID: 24176438DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the Catheterization laboratory

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 30, 2011

Study Start

June 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2017

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

PT(1)IT(13)HU(1)CH(1)