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NCT01796691 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— BOCLA-Mort  

Official title:
Optimized Antiplatelet Therapy With Aspirin and Clopidogrel Improves Mortality Compared to Standard Treatment.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01796691
Other study ID # BOCLAplan02
Secondary ID [Ruhr-University
Status Completed
Phase N/A
First received February 17, 2013
Last updated February 24, 2013
Start date January 2009
Est. completion date February 2013

Study information
Verified date February 2013
Source Ruhr University of Bochum
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- coronary stent implantation

Exclusion Criteria:

- no consent

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Cardiovascular Center, Ruhr-University Bochum Bochum NRW

Sponsors (1)
Lead Sponsor Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Neubauer H, Kaiser AF, Endres HG, Krüger JC, Engelhardt A, Lask S, Pepinghege F, Kusber A, Mügge A. 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. doi: 10.1186/1741-7015-9-3. — View Citation

Neubauer H, Lask S, Engelhardt A, Mügge A. How to optimise clopidogrel therapy? Reducing the low-response incidence by aggregometry-guided therapy modification. Thromb Haemost. 2008 Feb;99(2):357-62. doi: 10.1160/TH07-10-0624. — View Citation

Siller-Matula JM, Francesconi M, Dechant C, Jilma B, Maurer G, Delle-Karth G, Gouya G, Ruzicka K, Podczeck-Schweighofer A, Christ G. Personalized antiplatelet treatment after percutaneous coronary intervention: the MADONNA study. Int J Cardiol. 2013 Sep 1;167(5):2018-23. doi: 10.1016/j.ijcard.2012.05.040. Epub 2012 May 30. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse cardiac events (MACE: mortality,rehospitalisation,myocardial infarction) MACE-rate Follow up for up to 12 months (retrospective analysis) No
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