Patients with coronary artery disease and ongoing treatment with an oral anticoagulant agent (warfarin), who have indication for treatment with a drug-eluting stent and therefore have indication for aspirin and clopidogrel treatment. MedDRA version: 13.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Plavix (clopidogrel)
Pharmaceutical Form: Tablet
INN or Proposed INN: CLOPIDOGREL
CAS Number: 113665-84-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Aarhus University Hospital, Skejby
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with an indication for oral anticoagulation and a DES implantation. 2. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study. 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. Previous stent thrombosis 3. DES in left main 4. Cardiogenic shock 5. Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance. 6. Planned major surgery within the next 9 months with the need to discontinue antiplatelet therapy 7. Active bleeding; bleeding diathesis; recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; 8. Known allergy or intolerance to the study medications: ASA, clopidogrel, phenprocoumon, warfarin and heparin. 9. Pregnancy (present, suspected or planned) or positive pregnancy test. (In women with childbearing potential a pregnany test is mandatory.) 10. Relevant hematologic deviations: hemoglobin 600 x 109 cells/L. 11. Previous enrollment in this trial. 12. Patient’s inability to fully comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the duration of clopidogrel treatment after coronary drug-eluting stent implantation in patients treated with an oral anticoagulant agent (warfarin) and aspirin. The primary hypothesis is that 6 weeks clopidogrel treatment is superior to 6 months clopidogrel treatment.;Secondary Objective: Ischemic complications (composite of cardiac death, myocardial infarction, stentthrombosis or ischemic stroke) Bleeding complications (TIMI major bleeding) ;Primary end point(s): To determine whether there are differences in the cumulative incidence of death, myocardial infarction, definite stent thrombosis, stroke or TIMI major bleeding during nine months follow-up in patients receiving a 6 week or a 6 month duration of clopidogrel therapy together with ASA and oral anticoagulation. | — |
Countries
Denmark
Outcome results
None listed