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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Optimizing ASA and clopidogrel treatment

• Registration Number: NCT01212302
• Lead Sponsor: Ruhr University of Bochum

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2010-09
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Results First Submitted: 2011-02-28
• Results First Submitted QC: 2011-08-11
• Last Update Submitted: 2011-08-11
• Results First Posted: 2011-09-16
• Last Update Posted: 2011-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aspirin, clopidogrel	Optimizing ASA and clopidogrel treatment	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)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cardiovascular Center, Ruhr University Bochum, St. Josef - Hospital, Gudrunstrasse 56; 🇩🇪 Bochum, NRW, Germany