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

NCT01796691 | Completed

• 2 other identifiers: BOCLAplan02[Ruhr-University Bochum]
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.

Conditions

Coronary Artery Disease

Keywords

Clopidogrel; aspirin; low response; platelet aggregation; Acute Coronary Syndrome; Coronary Stent Implantation

Outcome Measures

Primary Outcomes (1)

• Adverse cardiac events (MACE: mortality,rehospitalisation,myocardial infarction)

  MACE-rate

  Follow up for up to 12 months (retrospective analysis)

Study Arms (2)

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.)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients following coronary stenting if informed consent was obtained

You may qualify if:

• coronary stent implantation

You may not qualify if:

• no consent

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Cardiovascular Center, Ruhr-University Bochum

Bochum, North Rhine-Westphalia, D-44791, Germany

Location

Related Publications (3)

• 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.

  PMID: 21226927 BACKGROUND

• 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.

  PMID: 18278186 BACKGROUND

• 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.

  PMID: 22656044 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Horst Neubauer, MD

  Ruhr-University Bochum, Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD, MD

Study Record Dates

• First Submitted: February 17, 2013
• First Posted: February 22, 2013
• Study Start: January 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

DE (1)