Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)

Ischemic Heart Disease Clinical Trial

— PROTECT  

Official title:

PROTECT Trial: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476957
• Other study ID #: Version 1.0 - 12 April 2007
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2007
• Last updated: November 3, 2014
• Start date: June 2007
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeAustralia: Human Research Ethics CommitteeAustria: EthikkommissionBelgium: Institutional Review BoardBrazil: National Committee of Ethics in ResearchCanada: Canadian Institutes of Health ResearchChina: Ethics CommitteeFinland: Ethics CommitteeFrance: Institutional Ethical CommitteeGermany: Ethics CommissionGreece: Ethics CommitteeHong Kong: Ethics CommitteeIndia: Institutional Review BoardIreland: Medical Ethics Research CommitteeIsrael: Ethics CommissionItaly: Ethics CommitteeItaly: Ministry of HealthJordan: Ethical CommitteeNetherlands: Medical Ethics Review Committee (METC)New Zealand: Institutional Review BoardNorway:National Committee for Medical and Health Research EthicsSouth Africa: National Health Research Ethics CouncilSpain: Ethics CommitteeSweden: Regional Ethical Review BoardSwitzerland: EthikkommissionUnited Kingdom: Research Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200 hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late stent thrombosis resulting in less deaths and myocardial infarctions.

Study Stents:

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System or next generation model Cordis Cypher® Sirolimus-eluting Coronary Stent, Cordis Cypher Select® Sirolimus-eluting Coronary Stent or next generation model

Primary Objective: To compare overall stent thrombosis rate of the Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation

Secondary Objective: To compare the composite endpoint of total death or cardiac death combined with the number of patients with all non-fatal myocardial infarctions as well as the number of patients with large non-fatal myocardial infarctions for Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation.

To assess the safety and efficacy in patient subgroups with specific demographics, clinical indications and/or vessel- or lesion characteristics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8709
• Est. completion date: July 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is > 18 years of age (or minimum age as required by local regulations).

2. The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form".

3. All lesions requiring interventions (target lesions - one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor® Zotarolimus Eluting Coronary Stent System or Cypher® Sirolimus-eluting Coronary Stent*.

4. Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor® Zotarolimus Eluting Coronary Stent System and Cypher® Sirolimus-eluting Coronary Stent. Patients should qualify for both systems before randomization*.

5. The patient is willing and able to cooperate with study procedures and required follow up visits.

Exclusion Criteria:

1. Women with known pregnancy or who are lactating.

2. Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.

3. Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.

4. Previous brachy-therapy.

5. Previous implantation of a drug eluting stent.

6. Previous implantation of a bare metal stent in the preceding year.

7. Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery.

8. Current medical condition with a life expectancy of less than 3 years.

9. Manifest acute severe heart failure (Killip class III-IV).

10. The patient is currently, and during the first 3 years of the PROTECT trial, participating in another investigational device or drug study that clinically interferes with the PROTECT-study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the PROTECT-study once.

11. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.

12. Patients on warfarin or similar anti-coagulant therapy.

13. Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.

14. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.

15. Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.

16. Transplant patients.

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Stent
Stent implantation
• Stent
Stent implantation

Locations

Country	Name	City	State
Netherlands	196 enrolling sites Worldwide	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Vascular	Medtronic Bakken Research Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Camenzind E, Wijns W, Mauri L, Boersma E, Parikh K, Kurowski V, Gao R, Bode C, Greenwood JP, Gershlick A, O'Neill W, Serruys PW, Jorissen B, Steg PG; PROTECT Steering Committee and Investigators. Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation. Am Heart J. 2009 Dec;158(6):902-909.e5. doi: 10.1016/j.ahj.2009.10.002. — View Citation

Camenzind E, Wijns W, Mauri L, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Boersma E, Vranckx P, McFadden E, Serruys PW, O'Neil WW, Jorissen B, Van Leeuwen F, Steg PG; PROTECT Steering Committee and Investigators. Stent thrombosis and major clinica — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation	Definite or probable stent thrombosis rate.	3 years	Yes
Secondary	Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions	Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions	3 years	Yes