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

Ruhr University of Bochum500 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Coronary Artery Disease

Interventions

Optimizing ASA and clopidogrel treatmentDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Bochum, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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).

Time frame: 2 years

Data from ClinicalTrials.gov

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