Clinical trial NCT01069003: EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Heart Disease
Cardiovascular Disease
Platelet Aggregation Inhibitors
Dual Antiplatelet Therapy
Clopidogrel
Prasugrel
Vascular Disease
Myocardial Ischemia
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 2272
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects
timeFrame: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)
measure: Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects
timeFrame: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)
measure: Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects
timeFrame: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Anderson
country: United States
facility: AnMed Health Medical Center
state: South Carolina
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Donald Cutlip, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fletcher Allen Hospital
name: Harold Dauerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cutlip DE, Kereiakes DJ, Mauri L, Stoler R, Dauerman HL; EDUCATE Investigators. Thrombotic complications associated with early and late nonadherence to dual antiplatelet therapy. JACC Cardiovasc Interv. 2015 Mar;8(3):404-410. doi: 10.1016/j.jcin.2014.10.017. Epub 2015 Feb 18.