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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Arm | Placebo Comparator | 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. |
|
| Thienopyridine Therapy | Active Comparator | 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. |
|
| Surveillance Arm | Other | Non randomized subjects followed through 24 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Arm | Drug | Placebo and ASA (75 mg - 325 mg) |
| |
| Thienopyridine Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) |
| 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) |
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ENROLLMENT INCLUSION CRITERIA
ENROLLMENT EXCLUSION CRITERIA
RANDOMIZATION INCLUSION CRITERIA AT 12 MONTHS
RANDOMIZATION EXCLUSION CRITERIA AT 12 MONTHS
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| Name | Affiliation | Role |
|---|---|---|
| Donald Cutlip, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Harold Dauerman, MD | Fletcher Allen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AnMed Health Medical Center | Anderson | South Carolina | 29621 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25703885 | Derived | Cutlip DE, Kereiakes DJ, Mauri L, Stoler R, Dauerman HL; EDUCATE Investigators. Thrombotic complications associated with early and late nonadherence to dual antiplatelet therapy. JACC Cardiovasc Interv. 2015 Mar;8(3):404-410. doi: 10.1016/j.jcin.2014.10.017. Epub 2015 Feb 18. |
| Label | URL |
|---|---|
| Native DAPT Study Web Site | View source |
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Enrolled 2272 but only 2262 subjects were analysis receiving the Endeavor stent only.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 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) |
| FG001 | 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) |
| FG002 | Surveillance Arm | Non randomized subjects followed for total of 24 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The intent to treat arm contains non randomized subjects followed through 24 months
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects | Posted | Number | Percentage of participants | Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) |
|
All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sidney Cohen, Sr. Clinical Medical Advisor | Medtronic | 707-591-7277 | sidney.a.cohen@medtonic.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| Drug |
Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg) |
|
| Surveillance Arm | Device | Non randomized arm to understand clinical outcomes in a commercial setting |
|
| Harvard Clinical Research Institute | View source |
| 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) |
| BG002 | Surveillance Arm | Non randomized subjects followed for total of 24 months |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | Surveillance Arm | Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization. |
|
|
| 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 | Posted | Number | percentage of participants | Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) |
|
|
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| Primary | Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects | Posted | Number | Percentage of participants | Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months) |
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| 117 |
| 399 |
| 0 |
| 399 |
| EG001 | 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) | 111 | 412 | 0 | 412 |
| EG002 | Surveillance Arm | Non randomized subjects followed through 24 months | 664 | 1,451 | 90 | 1,451 |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Angina Unstable | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Enzymes Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiogenic Shock | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Coronary Artery Occlusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Coronary Artery Stenosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hernia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| In-Stent Coronary Artery Restenosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Ischaemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Retroperitoneal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Therapeutic Embolisation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| Thrombosis In Device | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
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