Coronary Artery DiseasePhase 4EDUCATENCT01069003

EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events

A Phase 4 study testing Thienopyridine Therapy and Surveillance Arm in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Thienopyridine Therapy and Surveillance Arm
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,272 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Apr 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

AnMed Health Medical Center
Anderson, South Carolina, 29621

Other trials in United States

About this study

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

Read the 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.

Conditions: Coronary Artery Disease
Being tested: Placebo Arm, Thienopyridine Therapy, Surveillance Arm
Keywords: Heart Disease, Cardiovascular Disease, Platelet Aggregation Inhibitors, Dual Antiplatelet Therapy, Clopidogrel, Prasugrel, Vascular Disease, Myocardial Ischemia
Medical subject headings: Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo ArmDrug
Placebo and ASA (75 mg - 325 mg)
Thienopyridine TherapyDrug
Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)
Surveillance ArmDevice
Non randomized arm to understand clinical outcomes in a commercial setting

Study groups in NCT01069003
Study group	Role	What they receive
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. Receives: Drug: Placebo Arm
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. Receives: Drug: Thienopyridine Therapy
Surveillance Arm	Other	Non randomized subjects followed through 24 months Receives: Device: Surveillance Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects
Measured: 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
Measured: 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
Measured: Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Apr 2014

First posted17 Feb 2010 (estimated)
Study startApr 2010
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 2,272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01069003
Sponsor's protocol ID: IP114
Acronym: EDUCATE
Status last verified: Dec 2015
First submitted: 12 Feb 2010
Last updated: 20 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 25703885

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01069003
Acronym / sponsor ID: EDUCATE / IP114
Conditions: Coronary Artery Disease
Keywords: Heart Disease, Cardiovascular Disease, Platelet Aggregation Inhibitors, Dual Antiplatelet Therapy, Clopidogrel, Prasugrel, Vascular Disease, Myocardial Ischemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,272 participants (actual)
Lead sponsor: Medtronic VascularIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 17 Feb 2010 (estimated)
Results: Posted 20 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo Arm	Placebo comparator	Drug: Placebo ArmSubjects 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	Drug: Thienopyridine TherapySubjects 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	Device: Surveillance ArmNon randomized subjects followed through 24 months

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo ArmPlacebo and ASA (75 mg - 325 mg)	Drug	Placebo Arm
Thienopyridine TherapyPrasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)	Drug	Thienopyridine Therapy
Surveillance ArmNon randomized arm to understand clinical outcomes in a commercial setting	Device	Surveillance Arm

Primary outcome

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)
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)
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)

Results and safety

Results posted to the registry on 20 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	399	353
Thienopyridine Therapy	412	358
Surveillance Arm	1,451	976

Primary outcome: 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). Number. Unit: Percentage of participants

Measure	Placebo Arm n = 392	Thienopyridine Therapy n = 393	Surveillance Arm n = 1451
Value	4.3	4.8	16.9

Primary outcome: 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). Number. Unit: percentage of participants

Measure	Placebo Arm n = 392	Thienopyridine Therapy n = 393	Surveillance Arm n = 1451
Value	1.0	0.5	2.4

Primary outcome: 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). Number. Unit: Percentage of participants

Measure	Placebo Arm n = 392	Thienopyridine Therapy n = 393	Surveillance Arm n = 1451
Value	1.8	2.0	4.8

Adverse events

Time frame: All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Arm	117 of 399 (29.3%)	0 of 399 (0%)	Not reported
Thienopyridine Therapy	111 of 412 (26.9%)	0 of 412 (0%)	Not reported
Surveillance Arm	664 of 1,451 (45.8%)	90 of 1,451 (6.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25703885Cutlip 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.
Native DAPT Study Web SiteLink provided by the sponsor.
Harvard Clinical Research InstituteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donald Cutlip, MD principal investigator

Beth Israel Deaconess Medical Center

Harold Dauerman, MD principal investigator

Fletcher Allen Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Thienopyridine Therapy and Surveillance Arm in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01069003, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.