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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00776633
Other study ID # GE IDE No. A01508
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received October 20, 2008
Last updated August 29, 2016
Start date September 2008
Est. completion date September 2014

Study information

Verified date August 2014
Source Deutsches Herzzentrum Muenchen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The investigators hypothesize that reducing the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation is associated with improved clinical outcomes in patients on ASA and an oral anticoagulant.


Description:

The introduction of drug-eluting stents (DES) was associated not only with a widening of the indication for percutaneous coronary intervention (PCI) but also with longer antithrombotic therapy duration. Dual antiplatelet therapy with ASA and a thienopyridine is very efficient in preventing adverse events after coronary stenting but it is inferior to oral anticoagulation (OAC) to reduce the risk of stroke in patients with atrial fibrillation. OAC is also superior to antiplatelet therapy in patients with mechanical heart valves and the therapy of choice for the treatment of deep vein thrombosis and pulmonary embolism. OAC is also administered for left ventricular thrombi and low ejection fraction. There is an increasing number of patients undergoing coronary stenting who are in need of life-long anticoagulation therapy and would therefore require a triple therapy consisting of aspirin, clopidogrel and oral anticoagulation. As oral anticoagulation and antithrombotic therapy impair primary and secondary hemostasis there are concerns that adding warfarin to dual antiplatelet therapy might cause increased bleeding rates. Several studies have retrospectively assessed efficacy and safety in patients receiving a triple therapy with various results: major bleeding rates varied from 3,1%-14,9% with total bleeding rates up to 27,5%. Prospective randomized data on this topic are not available. Therefore the aim of this study is to compare a 6 week versus a 6 month triple therapy after DES implantation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 614
Est. completion date September 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Key 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.

Key Exclusion Criteria:

1. Age =18 years

2. Previous stent thrombosis

3. DES in left main

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
aspirin
6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation
clopidogrel
6 months triple therapy with aspirin, clopidogrel and oral anticoagulation
oral anticoagulation


Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus
Germany 1. Medizinische Klinik, Klinikum rechts der Isar München
Germany Deutsches Herzzentrum München Munich

Sponsors (1)

Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen

Countries where clinical trial is conducted

Denmark,  Germany, 

References & Publications (2)

Rubboli A, Halperin JL, Airaksinen KE, Buerke M, Eeckhout E, Freedman SB, Gershlick AH, Schlitt A, Tse HF, Verheugt FW, Lip GY. Antithrombotic therapy in patients treated with oral anticoagulation undergoing coronary artery stenting. An expert consensus document with focus on atrial fibrillation. Ann Med. 2008;40(6):428-36. doi: 10.1080/07853890802089786. Review. — View Citation

Schömig A, Neumann FJ, Kastrati A, Schühlen H, Blasini R, Hadamitzky M, Walter H, Zitzmann-Roth EM, Richardt G, Alt E, Schmitt C, Ulm K. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med. 1996 Apr 25;334(17):1084-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding. 9 months Yes
Secondary Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke) 9 months Yes
Secondary Bleeding complications (Major bleeding) 9 months Yes
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