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Optimizing Aspirin and Clopidogrel Therapy (BOchum CLopidogrel and Aspirin Plan) (BOCLAplan)

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ClinicalTrials.gov Identifier: NCT01212302
Recruitment Status : Completed
First Posted : September 30, 2010
Results First Posted : September 16, 2011
Last Update Posted : September 16, 2011
Sponsor:
Information provided by:
Ruhr University of Bochum

Tracking Information
First Submitted Date  ICMJE September 29, 2010
First Posted Date  ICMJE September 30, 2010
Results First Submitted Date  ICMJE February 28, 2011
Results First Posted Date  ICMJE September 16, 2011
Last Update Posted Date September 16, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description) [ Time Frame: 2 years ]
In patients treated with aspirin and clopidogrel aggregometry was performed and depending on the results the patients were either responder or low-responder of antiplatelet therapy. The following definitions were used for clopidogrel low response (CLR: >5 ohm when stimulated with adenosine diphosphate (ADP) 5 μM) and ASA low response (ALR: >0 ohm;stimulated with arachidonic acid 10 μM) with the ChronoLog 590 aggregometer. In the case of low-response alternative antiplatelet therapy was modified according to the study plan (see protocol section).
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2010)
Platelet function testing to evaluate responder and low-responder of antiplatelet therapy [ Time Frame: 2 years ]
The patients with aspirin and clopidogrel will be measured with aggregometry and depending on the results the patients will be responders or low-responders. In the later case alternative antiplatelet therapy according to the study plan will be administered
Change History Complete list of historical versions of study NCT01212302 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Aspirin and Clopidogrel Therapy (BOchum CLopidogrel and Aspirin Plan)
Official Title  ICMJE Optimizing Therapy With Aspirin and Clopidogrel. The BOchum CLopidogrel and Aspirin Plan to Improve Dual Antiplatelet Therapy.
Brief Summary Dual antiplatelet therapy with acetylsalicylic acid (ASA, aspirin) and clopidogrel is of great importance for treatment following coronary stenting. Unfortunately the variable platelet inhibitory effectiveness compromises the antithrombotic benefit of dual antiplatelet therapy. The aim of this prospective single centre study was to reduce the low response incidence of dual antiplatelet therapy with ASA and clopidogrel based on a standardized therapy algorithm.
Detailed Description Platelet function testing using whole blood aggregometry was performed 48 hours following coronary stenting (either acute coronary syndromes or stable coronary artery disease). The antiplatelet therapy included a loading dose of 600 mg clopidogrel and 500 mg ASA, followed by 75 mg clopidogrel and 100 mg ASA once daily. Clopidogrel low-response (CLR) and/or ASA (ASA low response) were treated according to a structured therapy plan.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Drug: Optimizing ASA and clopidogrel treatment

ASA 100 mg, ASA 300 mg, ASA 500 mg

Clopidogrel 75 mg, Clopidogrel 150 mg, Ticlopidine 2x 250 mg, Prasugrel 10 mg. Intervention List:

In the case of clopidogrel low-response, the maintenance dose was doubled (repeated loading dose followed by 150 mg daily), and when still ineffective ticlopidine or prasugrel, if available and not contraindicated, were used. ASA low-responders were treated by increasing the dose to 300 mg in a first step or to 500 mg ASA when the first modification was not sufficient.

Other Name: ASA (aspirin), Clopidogrel (Plavix)
Study Arms  ICMJE Experimental: aspirin, clopidogrel
If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
Intervention: Drug: Optimizing ASA and clopidogrel treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2010)
500
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with stable coronary artery disease (CAD) or acute coronary syndromes (ACS) following percutaneous coronary intervention (PCI)

Exclusion Criteria:

  • abnormal platelet count in patients,
  • severe liver disorders,
  • current gastrointestinal disorders,
  • current infections,
  • congestive heart failure,
  • known bleeding disorders,
  • treatment with bivalirudin or glycoprotein IIb/IIIa antagonists within the last 7 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01212302
Other Study ID Numbers  ICMJE BOCLAplan01
F654R ( Registry Identifier: F654R Ruhr-University Bochum )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Horst Neubauer, MD, Ruhr-University Bochum
Study Sponsor  ICMJE Ruhr University of Bochum
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Horst Neubauer, MD Ruhr-University Bochum, Cardiovascular Center
PRS Account Ruhr University of Bochum
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP