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

NCT01069003 | Completed Phase 4 Results DMC

• 1 other identifier: IP114
• Study Type: interventional
• Target: 2,272
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Heart Disease; Cardiovascular Disease; Platelet Aggregation Inhibitors; Dual Antiplatelet Therapy; Clopidogrel; Prasugrel; Vascular Disease; Myocardial Ischemia

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (3)

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.

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.

Drug: Thienopyridine Therapy

Surveillance Arm

OTHER

Non randomized subjects followed through 24 months

Device: Surveillance Arm

Interventions

Placebo Arm DRUG

Placebo and ASA (75 mg - 325 mg)

Placebo Arm

Thienopyridine Therapy DRUG

Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)

Thienopyridine Therapy

Surveillance Arm DEVICE

Non randomized arm to understand clinical outcomes in a commercial setting

Surveillance Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subject is "12 Month Clear".
• Subjects without known contraindication to dual antiplatelet therapy for at least 18 months after randomization.
• 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.

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (1)

AnMed Health Medical Center

Anderson, South Carolina, 29621, United States

Location

Related Publications (1)

• 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.

  PMID: 25703885 DERIVED

Related Links

• Native DAPT Study Web Site
• Harvard Clinical Research Institute

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Sidney Cohen, Sr. Clinical Medical Advisor
• Organization: Medtronic

sidney.a.cohen@medtonic.com

707-591-7277

Study Officials

• Donald Cutlip, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Harold Dauerman, MD

  Fletcher Allen Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 17, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 20, 2016
• Results First Posted: January 20, 2016

Record last verified: 2015-12

Locations

US (1)