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

Coronary Artery Disease Clinical Trial

— EDUCATE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069003
• Other study ID #: IP114
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2010
• Last updated: December 11, 2015
• Start date: April 2010
• Est. completion date: April 2014

Study information

• Verified date: December 2015
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2272
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Placebo Arm
Placebo and ASA (75 mg - 325 mg)
• Thienopyridine Therapy
Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)

Device:
• Surveillance Arm
Non randomized arm to understand clinical outcomes in a commercial setting

Locations

Country	Name	City	State
United States	AnMed Health Medical Center	Anderson	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes

External Links

•   FDA Web Site related to DAPT Study
•   Harvard Clinical Research Institute
•   Native DAPT Study Web Site