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
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease
Drug: Placebo Arm
Drug: Thienopyridine Therapy
Device: Surveillance Arm
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • 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 ]

Enrollment: 2272
Study Start Date: April 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo Arm
Placebo and ASA (75 mg - 325 mg)
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.
Drug: Thienopyridine Therapy
Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)
Surveillance Arm
Non randomized subjects followed through 24 months
Device: Surveillance Arm
Non randomized arm to understand clinical outcomes in a commercial setting

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069003

Locations
United States, South Carolina
AnMed Health Medical Center
Anderson, South Carolina, United States, 29621
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Donald Cutlip, MD Beth Israel Deaconess Medical Center
Principal Investigator: Harold Dauerman, MD Fletcher Allen Hospital
  More Information

Additional Information:
No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01069003     History of Changes
Other Study ID Numbers: IP114 
Study First Received: February 12, 2010
Results First Received: June 29, 2015
Last Updated: December 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Vascular:
Heart Disease
Cardiovascular Disease
Platelet Aggregation Inhibitors
Dual Antiplatelet Therapy
Clopidogrel
Prasugrel
Vascular Disease
Myocardial Ischemia

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Prasugrel
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on February 10, 2016