High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures

NCT ID: NCT01744613

Last Updated: 2013-01-14

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular procedures. The clinical significance of an inadequate response to clopidogrel following percutaneous coronary interventions has been recently recognized.This study was designed to investigate platelet responsiveness to Clopidogrel following endovascular therapy of peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel antiplatelet therapy.

Detailed Description

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Conditions

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Influence of PRU Values on Primary Outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Will include patients with PRU values above the optimal cut-off value determined by ROC analysis

No interventions assigned to this group

Group B

Will include patients with PRU values below the optimal cut-off value determined by ROC analysis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from Rutherford 3-6 stage of peripheral arterial disease scheduled to undergo femoropopliteal or and infrapopliteal angioplasty or stenting.
* Patients receiving Clopidogrel per os 75 mg daily at least 1 month prior and 1 year after the procedure.

Exclusion Criteria

* Acute limb ischemia
* Coagulation disorders
* Known allergy to clopidogrel
* Failure to comply with the antiplatelet treatment protocol
* Aortoiliac disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Patras

OTHER

Sponsor Role lead

Responsible Party

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SIABLIS DIMITRIOS

Dimitrios Siablis, Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dimitrios Siablis, MD, PhD

Role: STUDY_DIRECTOR

University Hospital of Patras

Dimitrios Karnabatidis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Stavros Spiliopoulos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Georgios Pastromas, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Konstantinos Katsanos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Locations

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Patras University Hospital

Rio, Achaia, Greece

Site Status

Countries

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Greece

References

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Spiliopoulos S, Pastromas G, Katsanos K, Kitrou P, Karnabatidis D, Siablis D. Platelet responsiveness to clopidogrel treatment after peripheral endovascular procedures: the PRECLOP study: clinical impact and optimal cutoff value of on-treatment high platelet reactivity. J Am Coll Cardiol. 2013 Jun 18;61(24):2428-2434. doi: 10.1016/j.jacc.2013.03.036. Epub 2013 Apr 16.

Reference Type DERIVED
PMID: 23602777 (View on PubMed)

Other Identifiers

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822

Identifier Type: -

Identifier Source: org_study_id

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