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

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Drug: Optimizing ASA and clopidogrel treatment	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	500 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Optimizing Therapy With Aspirin and Clopidogrel. The BOchum CLopidogrel and Aspirin Plan to Improve Dual Antiplatelet Therapy.
Study Start Date :	October 2008
Actual Primary Completion Date :	March 2010
Actual Study Completion Date :	April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin Clopidogrel Clopidogrel bisulfate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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)	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)

Arm

Intervention/treatment

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)

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)

Outcome Measures

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) [ 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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212302

Locations

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Germany
Cardiovascular Center, Ruhr University Bochum, St. Josef - Hospital, Gudrunstrasse 56
Bochum, NRW, Germany, D-44791

Sponsors and Collaborators

Ruhr University of Bochum

Investigators

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Principal Investigator:	Horst Neubauer, MD	Ruhr-University Bochum, Cardiovascular Center

More Information

Publications:

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. Review. Erratum in: Pharmacol Ther. 2010 Nov;128(2):385.

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.

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.

Neubauer H, Lask S, Engelhardt A, Mügge 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.

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. Epub 2007 Jan 29.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Neubauer H, Kaiser AF, Endres HG, Krüger JC, Engelhardt A, Lask S, Pepinghege F, Kusber A, Mügge 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.

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Responsible Party:	Horst Neubauer, MD, Ruhr-University Bochum
ClinicalTrials.gov Identifier:	NCT01212302 History of Changes
Other Study ID Numbers:	BOCLAplan01 F654R ( Registry Identifier: F654R Ruhr-University Bochum )
First Posted:	September 30, 2010 Key Record Dates
Results First Posted:	September 16, 2011
Last Update Posted:	September 16, 2011
Last Verified:	September 2010

Keywords provided by Ruhr University of Bochum:


Clopidogrel ASA Low Response Resistance

Additional relevant MeSH terms:

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Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Ticlopidine Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents

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