Triple Therapy in Patients on Oral Anticoagulation After... | NCT00776633

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

NCT00776633

Sponsor

Deutsches Herzzentrum Muenchen

Status

Unknown status

Last Update Posted

Aug 30, 2016Estimated

Enrollment

614Actual

Phase

Phase 4

Conditions

Coronary Artery Disease
Atrial Fibrillation

Interventions

aspirin
clopidogrel
oral anticoagulation

Countries

Denmark
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2013Actual

Completion Date

Sep 2014Estimated

First Submitted Date

Oct 20, 2008

First Submission Date that Met QC Criteria

Oct 20, 2008

First Posted Date

Oct 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2016

Last Update Posted Date

Aug 30, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

614Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
aspirin	Drug	6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation	Long triple Short triple

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding.		9 months

Secondary Outcomes

Measure	Description	Time Frame
Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke)		9 months
Bleeding complications (Major bleeding)		9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

Age ≤18 years
Previous stent thrombosis
DES in left main

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adnan Kastrati, MD	Deutsches Herzzentum München	Study Chair
Stefanie Schulz, MD	Deutsches Herzzentrum Muenchen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus		8200	Denmark
Deutsches Herzzentrum München

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18608125	Background	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.
8598866

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D001241	Aspirin
D000077144	Clopidogrel

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

ID	Term
D003324	Coronary Artery Disease
D001281	Atrial Fibrillation