ndersøgelse af 6-uger versus 6-måneders clopidogrel behandling hos patienter med samtidig aspirin og oral angikoagulans behandling efter implantation af en drug-eluting stent

Phase 1

• Conditions: 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: 13.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2011-000583-96-DK
• Lead Sponsor: Aarhus University Hospital, Skejby

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-19
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

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

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 < 10 g/dL platelet count < 100 x 109 cells/L or platelet count
> 600 x 109 cells/L.
11. Previous enrollment in this trial.
12. Patient’s inability to fully comply with the study protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>Bleeding complications (TIMI major bleeding)<br>;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.