The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent

The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent in the Patients With Coronary Artery Disease (DATE Registry)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00418860

Acronym

DATE

Enrollment

1200

Registered

2007-01-05

Start date

2006-09-30

Completion date

2009-04-30

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Angioplasty, Transluminal, Percutaneous Coronary, Stent thrombosis, Zotarolimus-eluting stent

Brief summary

The purpose of this study to determine whether the dual antiplatelet therapy (aspirin and clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in terms of death, myocardial infarction, or stent thrombosis.

Interventions

DRUGAspirin, Clopidogrel

Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with clinically significant de novo coronary artery disease * Stenting only with Endeavor® stents * The sum of stent length is less than 60 mm for one lesion. The sum of stent length in multiple lesions does not matter.

Exclusion criteria

* Cardiogenic shock * ST-elevation myocardial infarction within 48 hours of symptom onset * Prior implantation of drug-eluting stents * Left ventricular dysfunction (echocardiographic left ventricular ejection fraction \< 25%) * Stenting both branch of bifurcation lesion * Left main trunk lesion * Graft vessels * Patients who have to receive clopidogrel due to other conditions * Patients who have to receive warfarin, cilostazol or other antiplatelet therapy * Patient with chronic renal failure (S-Cr \> 2.0 mg/dl) * Hypersensitivity to clopidogrel or aspirin * Expectant survival less than 1 year * Women who plan to become pregnant * Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months) * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Design outcomes

Primary

Measure	Time frame
Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard	1 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026