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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting

NCT00661206

Coronary Artery Disease

UNKNOWN PHASE4

Anticoagulation in Stent Intervention

NCT01141153

Atrial Fibrillation Stroke

UNKNOWN PHASE4

Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy

NCT00944333

Angina Pectoris Silent Ischemia

TERMINATED PHASE3

Clopidogrel Monotherapy in Patients With High Bleeding Risk

NCT05223335

Bleeding Complications

COMPLETED PHASE4

Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation

NCT01233167

Coronary Artery Disease

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Short triple

6 weeks triple therapy

Group Type EXPERIMENTAL

aspirin

Intervention Type DRUG

6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation

clopidogrel

Intervention Type DRUG

6 months triple therapy with aspirin, clopidogrel and oral anticoagulation

oral anticoagulation

Intervention Type DRUG

Long triple

6 months triple therapy

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation

clopidogrel

Intervention Type DRUG

6 months triple therapy with aspirin, clopidogrel and oral anticoagulation

oral anticoagulation

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aspirin

6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation

Intervention Type DRUG

clopidogrel

6 months triple therapy with aspirin, clopidogrel and oral anticoagulation

Intervention Type DRUG

oral anticoagulation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.