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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Optimizing ASA and clopidogrel treatment
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Clopidogrel, ASA, Low Response, Resistance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiovascular Center, Ruhr University Bochum, St. Josef - Hospital, Gudrunstrasse 56

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aspirin, clopidogrel

Arm Description

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)

Outcomes

Primary Outcome Measures

Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)
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).

Secondary Outcome Measures

Full Information

First Posted
September 29, 2010
Last Updated
August 11, 2011
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT01212302
Brief Title
Optimizing Aspirin and Clopidogrel Therapy (BOchum CLopidogrel and Aspirin Plan)
Acronym
BOCLAplan
Official Title
Optimizing Therapy With Aspirin and Clopidogrel. The BOchum CLopidogrel and Aspirin Plan to Improve Dual Antiplatelet Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Clopidogrel, ASA, Low Response, Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aspirin, clopidogrel
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Optimizing ASA and clopidogrel treatment
Other Intervention Name(s)
ASA (aspirin), Clopidogrel (Plavix)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Neubauer, MD
Organizational Affiliation
Ruhr-University Bochum, Cardiovascular Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Center, Ruhr University Bochum, St. Josef - Hospital, Gudrunstrasse 56
City
Bochum
State/Province
NRW
ZIP/Postal Code
D-44791
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20570595
Citation
Geisler T, Gawaz M, Steinhubl SR, Bhatt DL, Storey RF, Flather M. Current strategies in antiplatelet therapy--does identification of risk and adjustment of therapy contribute to more effective, personalized medicine in cardiovascular disease? Pharmacol Ther. 2010 Aug;127(2):95-107. doi: 10.1016/j.pharmthera.2010.04.017. Epub 2010 Jun 1. Erratum In: Pharmacol Ther. 2010 Nov;128(2):385.
Results Reference
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PubMed Identifier
18765393
Citation
Collet JP, Silvain J, Landivier A, Tanguy ML, Cayla G, Bellemain A, Vignolles N, Gallier S, Beygui F, Pena A, Montalescot G. Dose effect of clopidogrel reloading in patients already on 75-mg maintenance dose: the Reload with Clopidogrel Before Coronary Angioplasty in Subjects Treated Long Term with Dual Antiplatelet Therapy (RELOAD) study. Circulation. 2008 Sep 16;118(12):1225-33. doi: 10.1161/CIRCULATIONAHA.108.776757. Epub 2008 Sep 2. Erratum In: Circulation.2008 Oct 14;118(16): e672.
Results Reference
background
PubMed Identifier
20708365
Citation
Bonello L, Armero S, Ait Mokhtar O, Mancini J, Aldebert P, Saut N, Bonello N, Barragan P, Arques S, Giacomoni MP, Bonello-Burignat C, Bartholomei MN, Dignat-George F, Camoin-Jau L, Paganelli F. Clopidogrel loading dose adjustment according to platelet reactivity monitoring in patients carrying the 2C19*2 loss of function polymorphism. J Am Coll Cardiol. 2010 Nov 9;56(20):1630-6. doi: 10.1016/j.jacc.2010.07.004. Epub 2010 Aug 12.
Results Reference
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PubMed Identifier
18278186
Citation
Neubauer H, Lask S, Engelhardt A, Mugge A. How to optimise clopidogrel therapy? Reducing the low-response incidence by aggregometry-guided therapy modification. Thromb Haemost. 2008 Feb;99(2):357-62. doi: 10.1160/TH07-10-0624.
Results Reference
background
PubMed Identifier
17261652
Citation
Angiolillo DJ, Shoemaker SB, Desai B, Yuan H, Charlton RK, Bernardo E, Zenni MM, Guzman LA, Bass TA, Costa MA. Randomized comparison of a high clopidogrel maintenance dose in patients with diabetes mellitus and coronary artery disease: results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) study. Circulation. 2007 Feb 13;115(6):708-16. doi: 10.1161/CIRCULATIONAHA.106.667741. Epub 2007 Jan 29.
Results Reference
background
PubMed Identifier
21226927
Citation
Neubauer H, Kaiser AF, Endres HG, Kruger JC, Engelhardt A, Lask S, Pepinghege F, Kusber A, Mugge A. Tailored antiplatelet therapy can overcome clopidogrel and aspirin resistance--the BOchum CLopidogrel and Aspirin Plan (BOCLA-Plan) to improve antiplatelet therapy. BMC Med. 2011 Jan 12;9:3. doi: 10.1186/1741-7015-9-3.
Results Reference
derived

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

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