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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Placebo Arm

Thienopyridine Therapy

Surveillance Arm

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Heart Disease, Cardiovascular Disease, Platelet Aggregation Inhibitors, Dual Antiplatelet Therapy, Clopidogrel, Prasugrel, Vascular Disease, Myocardial Ischemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

AnMed Health Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Other

Arm Label

Placebo Arm

Thienopyridine Therapy

Surveillance Arm

Arm 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.

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.

Non randomized subjects followed through 24 months

Outcomes

Primary Outcome Measures

Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects

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

Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects

Secondary Outcome Measures

Full Information

NCT ID

NCT01069003

First Posted

February 12, 2010

Last Updated

December 11, 2015

Sponsor

Medtronic Vascular

1. Study Identification

Unique Protocol Identification Number

NCT01069003

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Vascular

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Heart Disease, Cardiovascular Disease, Platelet Aggregation Inhibitors, Dual Antiplatelet Therapy, Clopidogrel, Prasugrel, Vascular Disease, Myocardial Ischemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

2272 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

Arm Title

Thienopyridine Therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Surveillance Arm

Arm Type

Other

Arm Description

Non randomized subjects followed through 24 months

Intervention Type

Drug

Intervention Name(s)

Placebo Arm

Intervention Description

Placebo and ASA (75 mg - 325 mg)

Intervention Type

Drug

Intervention Name(s)

Thienopyridine Therapy

Intervention Description

Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)

Intervention Type

Device

Intervention Name(s)

Surveillance Arm

Intervention Description

Non randomized arm to understand clinical outcomes in a commercial setting

Primary Outcome Measure Information:

Title

Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects

Time Frame

Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)

Title

Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects

Description

Time Frame

Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)

Title

Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects

Time Frame

Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald Cutlip, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Harold Dauerman, MD

Organizational Affiliation

Fletcher Allen Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

AnMed Health Medical Center

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25703885

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.

Results Reference

derived

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

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