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

Coronary Artery Disease Clinical Trial

— DATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418860
• Other study ID #: 2006-09-025
• Status: Completed
• Phase: N/A
• First received: January 3, 2007
• Last updated: August 10, 2011
• Start date: September 2006
• Est. completion date: April 2009

Study information

• Verified date: August 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: April 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Aspirin, Clopidogrel
Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Medtronic

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard		1 year	Yes