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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Placebo Arm; Device: Surveillance Arm; Drug: Thienopyridine Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069003

IP114

Details and patient eligibility

About

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.

Full description

To provide clinical information on rates of late and very late stent thrombosis after Endeavor Drug-eluting Stent (DES)placement in an all comers population with a broad range of bleeding and thrombosis risk. EDUCATE will further analyze the current practice of clinicians regarding temporary cessation of antiplatelet therapy and its association with clinical outcomes. In addition, patients included in this broad Endeavor registry will also be contributed to the DAPT native study population for analysis of 12 vs 30 months duration of dual antiplatelet therapy.

Enrollment: 2,272 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,272 participants in 3 patient groups, including a placebo group

Placebo Arm

Placebo Comparator group

Description:

Subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA). Eligible subjects are without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.

Treatment:

Drug: Placebo Arm

Thienopyridine Therapy

Active Comparator group

Description:

Subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA). Eligible subjects are without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.

Treatment:

Drug: Thienopyridine Therapy

Surveillance Arm

Other group

Description:

Non randomized subjects followed through 24 months

Treatment:

Device: Surveillance Arm