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

Ruhr University of Bochum

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Drug: Optimizing ASA and clopidogrel treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01212302

F654R (Registry Identifier)

BOCLAplan01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

aspirin, clopidogrel

Experimental group

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)

Treatment:

Drug: Optimizing ASA and clopidogrel treatment