Coronary Artery Disease
Conditions
Keywords
Heart Disease, Cardiovascular Disease, Platelet Aggregation Inhibitors, Dual Antiplatelet Therapy, Clopidogrel, Prasugrel, Vascular Disease, Myocardial Ischemia
Brief 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.
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.
Interventions
DRUGPlacebo Arm
Placebo and ASA (75 mg - 325 mg)
DRUGThienopyridine Therapy
Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)
DEVICESurveillance Arm
Non randomized arm to understand clinical outcomes in a commercial setting
Sponsors
Medtronic Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects | Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) | — |
| Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects | Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) | 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 | Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) | — |
Countries
United States
Participant flow
Pre-assignment details
Enrolled 2272 but only 2262 subjects were analysis receiving the Endeavor stent only.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Arm 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).
Placebo (12-Month Arm): Placebo
ASA: 75 mg - 325 mg Aspirin(ASA) | 399 |
| Thienopyridine Therapy 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).
Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg
ASA: 75 mg - 325 mg Aspirin(ASA) | 412 |
| Surveillance Arm Non randomized subjects followed for total of 24 months | 1,451 |
| Total | 2,262 |
Baseline characteristics
| Characteristic | Placebo Arm | Thienopyridine Therapy | Surveillance Arm | Total |
|---|---|---|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 10.7 | 62.5 years STANDARD_DEVIATION 10.7 | 64.6 years STANDARD_DEVIATION 11.3 | 63.3 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment Canada | 27 participants | 27 participants | 42 participants | 96 participants |
| Region of Enrollment United States | 372 participants | 385 participants | 1409 participants | 2166 participants |
| Sex: Female, Male Female | 122 Participants | 116 Participants | 449 Participants | 687 Participants |
| Sex: Female, Male Male | 277 Participants | 296 Participants | 1002 Participants | 1575 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 399 | 0 / 412 | 90 / 1,451 |
| serious Total, serious adverse events | 117 / 399 | 111 / 412 | 664 / 1,451 |
Outcome results
Primary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Arm | Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects | 1.8 Percentage of participants |
| Thienopyridine Therapy | Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects | 2.0 Percentage of participants |
| Surveillance Arm | Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects | 4.8 Percentage of participants |
Primary
Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects
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
Time frame: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Arm | Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects | 1.0 percentage of participants |
| Thienopyridine Therapy | Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects | 0.5 percentage of participants |
| Surveillance Arm | Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects | 2.4 percentage of participants |
Primary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Arm | Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects | 4.3 Percentage of participants |
| Thienopyridine Therapy | Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects | 4.8 Percentage of participants |
| Surveillance Arm | Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects | 16.9 Percentage of participants |