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
  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 (12-Month Arm)
Drug: Prasugrel and Clopidogrel (30-Month Arm)
Drug: ASA
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:
  • Incidence of cardiac death, myocardial infarction (MI), stent thrombosis, bleeding and DAPT compliance [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2500
Study Start Date: April 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: Placebo (12-Month Arm)
Placebo
Drug: ASA
75 mg - 325 mg Aspirin(ASA)
Other Name: Aspirin
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).
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

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.
  • 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.
  Contacts and Locations
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

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01069003     History of Changes
Other Study ID Numbers: IP114
Study First Received: February 12, 2010
Last Updated: November 1, 2013
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
Platelet Aggregation Inhibitors
Prasugrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on April 23, 2014