Phase 4
N=2,262
EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01069003 ↗Enrolled (actual)
2,262
Serious AEs
39.4%
Results posted
Jan 2016
Primary outcome: Primary: Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects — 4.3; 4.8; 16.9 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo Arm (Drug); Thienopyridine Therapy (Drug); Surveillance Arm (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Medtronic Vascular
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects |
4.3; 4.8; 16.9 | — |
| PRIMARY Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects |
1.0; 0.5; 2.4 | — |
| PRIMARY Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects |
1.8; 2.0; 4.8 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT01069003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.