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

This study has been completed.
Sponsor:
Information provided by:
Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01212302
First received: September 29, 2010
Last updated: August 11, 2011
Last verified: September 2010
  Purpose

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 Intervention
Coronary Artery Disease
Drug: Optimizing ASA and clopidogrel treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimizing Therapy With Aspirin and Clopidogrel. The BOchum CLopidogrel and Aspirin Plan to Improve Dual Antiplatelet Therapy.

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

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 ] [ Designated as safety issue: Yes ]

    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).



Enrollment: 500
Study Start Date: October 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01212302

Locations
Germany
Cardiovascular Center, Ruhr University Bochum, St. Josef - Hospital, Gudrunstrasse 56
Bochum, NRW, Germany, D-44791
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Horst Neubauer, MD Ruhr-University Bochum, Cardiovascular Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Horst Neubauer, MD, Ruhr-University Bochum
ClinicalTrials.gov Identifier: NCT01212302     History of Changes
Other Study ID Numbers: BOCLAplan01, F654R
Study First Received: September 29, 2010
Results First Received: February 28, 2011
Last Updated: August 11, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
Clopidogrel
ASA
Low Response
Resistance

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ticlopidine
Aspirin
Clopidogrel
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014