NCT01069003

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,272 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Placebo Arm	Placebo and ASA (75 mg - 325 mg)
DRUG	Thienopyridine Therapy	Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)
DEVICE	Surveillance Arm	Non randomized arm to understand clinical outcomes in a commercial setting

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-02-17
• Last updated: 2016-01-20
• Results posted: 2016-01-20

Locations

1 site across 1 country: United States