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

NCT00776633 | Unknown Phase 4 DMC

• 1 other identifier: GE IDE No. A01508
• Study Type: interventional
• Target: 614
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Coronary Artery Disease; Atrial Fibrillation

Keywords

aspirin; clopidogrel; oral anticoagulation; warfarin; drug eluting stent; phenprocoumon

Outcome Measures

Primary Outcomes (1)

• Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding.

  9 months

Secondary Outcomes (2)

• Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke)

  9 months

• Bleeding complications (Major bleeding)

  9 months

Study Arms (2)

Short triple

EXPERIMENTAL

6 weeks triple therapy

Drug: aspirin; Drug: clopidogrel; Drug: oral anticoagulation

Long triple

ACTIVE COMPARATOR

6 months triple therapy

Drug: aspirin; Drug: clopidogrel; Drug: oral anticoagulation

Interventions

aspirin DRUG

6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation

Long triple; Short triple

clopidogrel DRUG

6 months triple therapy with aspirin, clopidogrel and oral anticoagulation

Long triple; Short triple

oral anticoagulation DRUG

Long triple; Short triple

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an indication for oral anticoagulation and a DES implantation.
• Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.

You may not qualify if:

• Age ≤18 years
• Previous stent thrombosis
• DES in left main

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (3)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Deutsches Herzzentrum München

Munich, 80636, Germany

Location

1. Medizinische Klinik, Klinikum rechts der Isar

München, 81675, Germany

Location

Related Publications (4)

• 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.

  PMID: 18608125 BACKGROUND

• Schomig A, Neumann FJ, Kastrati A, Schuhlen 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. doi: 10.1056/NEJM199604253341702.

  PMID: 8598866 BACKGROUND

• Fiedler KA, Maeng M, Mehilli J, Schulz-Schupke S, Byrne RA, Sibbing D, Hoppmann P, Schneider S, Fusaro M, Ott I, Kristensen SD, Ibrahim T, Massberg S, Schunkert H, Laugwitz KL, Kastrati A, Sarafoff N. Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug-Eluting Stent Implantation: The ISAR-TRIPLE Trial. J Am Coll Cardiol. 2015 Apr 28;65(16):1619-1629. doi: 10.1016/j.jacc.2015.02.050.

  PMID: 25908066 DERIVED

• Fiedler KA, Byrne RA, Schulz S, Sibbing D, Mehilli J, Ibrahim T, Maeng M, Laugwitz KL, Kastrati A, Sarafoff N. Rationale and design of The 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 (ISAR-TRIPLE) study. Am Heart J. 2014 Apr;167(4):459-465.e1. doi: 10.1016/j.ahj.2014.01.005. Epub 2014 Jan 14.

  PMID: 24655693 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Adnan Kastrati, MD

  Deutsches Herzzentum München

  STUDY CHAIR

• Stefanie Schulz, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2014
• Last Updated: August 30, 2016

Record last verified: 2014-08

Locations

DK (1); DE (2)