Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) Study

Coronary Artery Disease Clinical Trial

— ZEUS  

Official title:

Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01385319
• Other study ID #: ZEUS-10-II
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 24, 2011
• Last updated: October 6, 2012
• Start date: June 2011
• Est. completion date: December 2017

Study information

• Verified date: October 2012
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Description:

The aim of this study is to conduct a multicenter, international, randomized trial to test whether the Endeavor stent is superior to BMS in terms of efficacy and safety in

1. Patients with coronary artery disease lesions at low risk of in-stent restenosis;

2. Patients at high risk for bleeding or carrying impossibility to comply with dual anti-platelet treatment at long-term.

3. Patients at high thrombosis risk due to systemic disorders or planned non-cardiac surgery within 12 months

As the use of DES in these two patient/lesion subsets is debated due to lack of evidence, patients fulfilling at least one of these three medical conditions qualify for bare metal stent implantation and physicians may believe DES to be even contra-indicated in such cases. The current protocol has been developed on purpose to address the value of the Endeavor Sprint stent, which differs in many aspects from other FDA approved DES, including fast and complete degree of strut coverage after implantation and quick release of active drug after deployment (~15 days) which may help decreasing the need for prolonged dual antiplatelet treatment down to 1 month as it is currently recommended for bare metal stent implantation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1606
• Est. completion date: December 2017
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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:

1. Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents

2. Recent (within previous 12 months) bleeding episode(s) which required medical attention

3. Previous bleeding episode(s) which required hospitalization if the bleeding diathesis has not been completely resolved (i.e. surgical removal of the bleeding source)

4. Age greater than 80

5. 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).

6. Known Anemia defined as repeatedly documented hemoglobin lower than 10 gr/dl which is not due to an acute and documented blood loss

7. 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:

1. Allergy/intolerance to aspirin

2. Allergy/intolerance to clopidogrel AND ticlopidine

3. Planned surgery (other than skin) within 12 months of percutaneous coronary intervention (PCI).

4. patient with cancers (other than skin) and life expectancy >1 year

5. Patients with systemic conditions associated with thrombosis diathesis (e.g., hematologic disorders and any known systemic conditions determining a pro-thrombotic state including immunological disorders)

Exclusion Criteria:

• Any of the following:

1. 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.

2. Subjects who are unable to give informed consent and assurance for complete contact through 12 months.

3. PCI with stenting in the previous 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Bare metal stent implantation
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.
• zotarolimus eluting stent
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.

Locations

Country	Name	City	State
Hungary	Albert Szent-Györgyi Clinical Center, University of Szeged	Szeged
Italy	Ospedale San Donato	Arezzo	AR
Italy	Ospedali Riuniti di Bergamo	Bergamo	BG
Italy	University Hospital of Ferrara	Ferrara
Italy	Istituto Clinico Sant'Ambrogio	Milano	MI
Italy	Azienda Unita' Sanitaria Locale Di Modena - Ospedale Baggiovara	Modena	MO
Italy	Clinica Mediterranea	Naples
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma	PR
Italy	Policlinico San Matteo	Pavia	PV
Italy	Ospedale di Ravenna	Ravenna	RA
Italy	Ospedale di Savigliano	Savigliano	CN
Italy	Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I	Torino	TO
Italy	Ospedale San Giovanni Bosco	Torino	TO
Italy	Policlinico San Marco	Zingonia	BG
Portugal	Hospital de Santa Cruz	Carnaxide
Switzerland	University Hospital of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Marco Valgimigli

Countries where clinical trial is conducted

Hungary,  Italy,  Portugal,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	Major adverse cardiovascular events including death for any cause, non-fatal myocardial infarction or target vessel revascularisation	12 months	Yes
Secondary	Death		12 months	Yes
Secondary	myocardial infarction		12 months	Yes
Secondary	TVR	target vessel revascularisation	12 months	No
Secondary	stent thrombosis		12 months	Yes