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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01069003
First received: February 12, 2010
Last updated: November 1, 2013
Last verified: November 2013

February 12, 2010
November 1, 2013
April 2010
May 2014   (final data collection date for primary outcome measure)
Incidence of cardiac death, myocardial infarction (MI), stent thrombosis, bleeding and DAPT compliance [ Time Frame: One year ] [ 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
  • Academic Research Consortium (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 ]
  • 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 (12-Month Arm)
    Placebo
  • Drug: Prasugrel and Clopidogrel (30-Month Arm)
    Prasugrel 5 or 10 mg; Clopidogrel 75 mg
  • Drug: ASA
    75 mg - 325 mg Aspirin(ASA)
    Other Name: Aspirin
  • Placebo Comparator: 12-Month Arm: Placebo & ASA
    Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).
    Interventions:
    • Drug: Placebo (12-Month Arm)
    • Drug: ASA
  • Active Comparator: 30-Month Arm: Clopidogrel & ASA: Prasugrel & ASA
    Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).
    Interventions:
    • Drug: Prasugrel and Clopidogrel (30-Month Arm)
    • Drug: ASA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2500
May 2014
May 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.
  • PCI 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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01069003
IP114
Yes
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
November 2013

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