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

NCT00418860 | Completed DMC

• 1 other identifier: 2006-09-025
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard

  1 year

Study Arms (1)

A

EXPERIMENTAL

Drug: Aspirin, Clopidogrel

Interventions

Aspirin, Clopidogrel DRUG

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

Also known as: plavix

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead
• Medtronic: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hyeon-Cheol Gwon, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 5, 2007
• Study Start: September 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2009
• Last Updated: August 11, 2011

Record last verified: 2011-08

Locations

KR (1)