Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation

Coronary Artery Disease Clinical Trial

— ISAR-TRIPLE  

Official title:

Intracoronary Stenting and Antithrombotic Regimen: Testing of a Six-week Versus a Six-month Clopidogrel Treatment Regimen in Patients With Concomitant Aspirin and Oral Anticoagulant Therapy Following Drug-eluting Stenting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00776633
• Other study ID #: GE IDE No. A01508
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

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