The Bochum Optimizing Clopidogrel-Aspirin Therapy and MORTality Study (BOCLA-Mort) (BOCLA-Mort)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01796691
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : February 26, 2013
Information provided by (Responsible Party):
Horst Neubauer, Ruhr University of Bochum

Brief Summary:
Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.

Condition or disease
Coronary Artery Disease

Detailed Description:
The study is aimed to evaluate if optimized antiplatelet treatment using a test and treat algorithm (with whole blood aggregometry) is able to improve clinical outcome of patients compared to standard treatment without platelet function testing.

Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Optimized Antiplatelet Therapy With Aspirin and Clopidogrel Improves Mortality Compared to Standard Treatment.
Study Start Date : January 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Standard therapy
Antiplatelet therapy following coronary stenting without platelet function testing
Optimized antiplatelet therapy

Platelet function testing and according to a test and treat strategy improve the antiplatelet therapy in low-responder.

Treatment adjustments were done as published before - see BOCLA-Plan manuscript. (Reference: Tailored antiplatelet therapy can overcome clopidogrel and aspirin resistance--the BOchum CLopidogrel and Aspirin Plan (BOCLA-Plan) to improve antiplatelet therapy. BMC Med. 2011 Jan 12;9:3.)

Primary Outcome Measures :
  1. Adverse cardiac events (MACE: mortality,rehospitalisation,myocardial infarction) [ Time Frame: Follow up for up to 12 months (retrospective analysis) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients following coronary stenting if informed consent was obtained

Inclusion Criteria:

  • coronary stent implantation

Exclusion Criteria:

  • no consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01796691

Cardiovascular Center, Ruhr-University Bochum
Bochum, NRW, Germany, D-44791
Sponsors and Collaborators
Ruhr University of Bochum
Principal Investigator: Horst Neubauer, MD Ruhr-University Bochum, Cardiovascular Center

Responsible Party: Horst Neubauer, PHD, MD, Ruhr University of Bochum Identifier: NCT01796691     History of Changes
Other Study ID Numbers: BOCLAplan02
[Ruhr-University Bochum] ( Registry Identifier: F654R )
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013

Keywords provided by Horst Neubauer, Ruhr University of Bochum:
low response
platelet aggregation
Acute Coronary Syndrome
Coronary Stent Implantation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents