Patients with established coronary artery disease on chronic clopidogrel therapy at 6 months after coronary drug eluting stent implantation. MedDRA version: 17.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Plavix
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation 2. Informed, written consent by the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age =18 years 2. Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization 3. Previous stent thrombosis 4. DES in left main coronary artery 5. STEMI and NSTEMI during the last 6 months 6. Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance 7. Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy 8. Active bleeding; bleeding diathesis; history intracranial bleeding 9. Oral anticoagulation therapy with coumadin derivatives 10. Known allergy or intolerance to the study medications: aspirin and clopidogrel 11. Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory) 12. Patient’s inability to fully comply with the study protocol 13. Prior enrollment in the same clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The hypothesis to be tested is that a clopidogrel therapy duration of 6 months after coronary drug-eluting stent implantation is associated with a clinical outcome that is not inferior to that of a 12-month therapy. The primary end point of the study is a composite of death, myocardial infarction, stent thrombosis (definite or probable according to Academic Research Consortium [ARC] criteria), stroke or TIMI major bleeding. ;Secondary Objective: The secondary endpoint contains the individual components of the primary endpoint. ;Primary end point(s): The hypothesis to be tested is that a clopidogrel therapy duration of 6 months after DES implantation is associated with a clinical outcome that is not inferior to that of a 12-month therapy. The primary end point of the study is a composite of death, myocardial infarction, stent thrombosis (definite or probable according to Academic Research Consortium [ARC] criteria), stroke or TIMI major bleeding. ;Timepoint(s) of evaluation of this end point: 9 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint contains the individual components of the primary endpoint: Incidence of death Incidence of myocardial infarction Incidence of stent thrombosis Incidence of stroke Incidence of TIMI major bleeding at 9 months after randomization.;Timepoint(s) of evaluation of this end point: 9 months after randomization | — |
Countries
Austria, Belgium, China, Denmark, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Switzerland, United States
Contacts
Public ContactISAResearch Center
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
Outcome results
None listed