NCT01212302

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

Optimizing Therapy With Aspirin and Clopidogrel. The BOchum CLopidogrel and Aspirin Plan to Improve Dual Antiplatelet Therapy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Ruhr University of Bochum · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2010-09-30
• Last updated: 2011-09-16
• Results posted: 2011-09-16

Locations

1 site across 1 country: Germany