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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01069003
First received: February 12, 2010
Last updated: December 11, 2015
Last verified: December 2015

February 12, 2010
December 11, 2015
April 2010
April 2014   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects [ Time Frame: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) ] [ Designated as safety issue: Yes ]
Incidence of cardiac death, MI, stent thrombosis, bleeding and DAPT compliance [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01069003 on ClinicalTrials.gov Archive Site
Not Provided
  • ARC defined definite and probable stent thrombosis in non-randomized subjects [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • Combined rate of cardiac death and MI in non-randomized subjects [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • Composite of death, target vessel MI, stroke, and major bleeding in non-randomized subjects [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • DAPT compliance rates at each follow up interval in non-randomized subjects [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Composite of all death, myocardial infarction (MI) and stroke (defined as MACCE) for randomized subjects [ Time Frame: From 12 - 33 months ] [ Designated as safety issue: Yes ]
  • Incidence of ARC definite or probable stent thrombosis (ST) and major bleeding (GUSTO classification, severe and moderate bleeding combined) [ Time Frame: From 12 - 33 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events
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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Placebo Arm
    Placebo and ASA (75 mg - 325 mg)
  • Drug: 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
  • Placebo Comparator: Placebo Arm
    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.
    Intervention: Drug: Placebo Arm
  • Active Comparator: Thienopyridine Therapy
    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.
    Intervention: Drug: Thienopyridine Therapy
  • Surveillance Arm
    Non randomized subjects followed through 24 months
    Intervention: Device: Surveillance Arm
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):404-10. doi: 10.1016/j.jcin.2014.10.017. Epub 2015 Feb 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2272
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01069003
IP114
Yes
Not Provided
Not Provided
Medtronic Vascular
Medtronic Vascular
Not Provided
Principal Investigator: Donald Cutlip, MD Beth Israel Deaconess Medical Center
Principal Investigator: Harold Dauerman, MD Fletcher Allen Hospital
Medtronic Vascular
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP