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

NCT ID: NCT01796691

Last Updated: 2013-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-02-28

Brief Summary

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Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Standard therapy

Antiplatelet therapy following coronary stenting without platelet function testing

No interventions assigned to this group

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.)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* coronary stent implantation

Exclusion Criteria

* no consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Horst Neubauer

PHD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Horst Neubauer, MD

Role: PRINCIPAL_INVESTIGATOR

Ruhr-University Bochum, Cardiovascular Center

Locations

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Cardiovascular Center, Ruhr-University Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Neubauer H, Kaiser AF, Endres HG, Kruger JC, Engelhardt A, Lask S, Pepinghege F, Kusber A, Mugge 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.

Reference Type BACKGROUND
PMID: 21226927 (View on PubMed)

Neubauer H, Lask S, Engelhardt A, Mugge 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.

Reference Type BACKGROUND
PMID: 18278186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22656044 (View on PubMed)

Other Identifiers

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[Ruhr-University Bochum]

Identifier Type: REGISTRY

Identifier Source: secondary_id

BOCLAplan02

Identifier Type: -

Identifier Source: org_study_id

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