EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

EDUCATE is a prospective, multi-center study designed to collect real-world safety and clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet therapy (DAPT) drug regimen.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medtronic Vascular
• Treatments: Aspirin; Clopidogrel; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride

Criteria

ENROLLMENT INCLUSION CRITERIA

• Patient is older than 18 years.

• The patient or patient's legal representative has consented to participate and has authorized the collection and release of his medical information by signing the "Subject Informed Consent Form".

• Patients undergoing percutaneous intervention with Endeavor stent deployment (or has within 24 hours).

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

ENROLLMENT EXCLUSION CRITERIA

• Index procedure stent placement with stent diameter < 2.5 mm or > 3.5 mm.

• Pregnant women.

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

• The patient is currently participating in another investigational device or drug study that clinically interferes with the EDUCATE Study. The patient may only be enrolled in the EDUCATE Study once.

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

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

• Patients treated with any stent other than the Endeavor stent during the index procedure.

RANDOMIZATION INCLUSION CRITERIA AT 12 MONTHS

• Subject is "12 Month Clear".

• Subjects without known contraindication to dual antiplatelet therapy for at least 18 months after randomization.

RANDOMIZATION EXCLUSION CRITERIA AT 12 MONTHS

• Pregnant women.

• Subject switched thienopyridine type or dose within 6 months prior to randomization.

• Planned surgery necessitating discontinuation of antiplatelet therapy within the 18 months following randomization.

• Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.

• Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.

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

• Subjects on warfarin or similar anticoagulant therapy.