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

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
EDUCATE: 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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Placebo Arm
* Drug: Thienopyridine Therapy
* Device: Surveillance Arm


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Arm<br>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. | Drug: Placebo Arm<br>* Placebo and ASA (75 mg - 325 mg)<br>|
| Active Comparator: Thienopyridine Therapy<br>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. | Drug: Thienopyridine Therapy<br>* Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)<br>|
| Other: Surveillance Arm<br>Non randomized subjects followed through 24 months | Device: Surveillance Arm<br>* Non randomized arm to understand clinical outcomes in a commercial setting<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects |  | Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) | 
| Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects | All definite and probable Stent Thrombosis (ST) are adjudicated by an independent committee according to the definition based on Academic Research Consortium (ARC) Definite is defined as angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region and at least 1 of the following: Acute ischemic symptoms, Ischemic ECG changes, Elevated cardiac biomarkers Probable defined as any unexplained death within the first 30 days of procedure and any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause | Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) | 
| Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects |  | Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Disease, Cardiovascular Disease, Platelet Aggregation Inhibitors, Dual Antiplatelet Therapy, Clopidogrel, Prasugrel, Vascular Disease, Myocardial Ischemia