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Residual Platelet Activity In Advanced Peripheral Artery Disease (TRAIANO)

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ClinicalTrials.gov Identifier: NCT01627431
Recruitment Status : Unknown
Verified November 2012 by Francesco Violi, University of Roma La Sapienza.
Recruitment status was:  Recruiting
First Posted : June 25, 2012
Last Update Posted : November 28, 2012
Sponsor:
Collaborator:
University of Florence
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza

Tracking Information
First Submitted Date  ICMJE June 14, 2012
First Posted Date  ICMJE June 25, 2012
Last Update Posted Date November 28, 2012
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
Residual Platelet Activity [ Time Frame: 2 years ]
Evaluate the high residual platelet activity prevalence in PAD patients
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01627431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
  • Target vessels thrombosis [ Time Frame: 2 years ]
    Evaluate the target vessels thrombosis incidence
  • Major Cardiac Events [ Time Frame: 2 years ]
    Evaluate the Major Cardiac Events (MACE) incidence in PAD patients undergoing the peripheral revascularization procedures.
  • Platelet aggregation tests [ Time Frame: 2 years ]
    Compare the different platelet aggregation tests specificity, sensitivity, accuracy and predictive values
  • Oxidative stress [ Time Frame: 2 years ]
    Evaluate platelet activation and oxidative stress indexes relationship
  • Laboratory tests predictive values [ Time Frame: 2 years ]
    Evaluate the different laboratory tests (platelet aggregation, oxidative stress markers, seric thromboxane) predictive values in identify recurrent thrombosis high risk patients
  • High risk patients score [ Time Frame: 2 years ]
    Validate a clinical-laboratoristic predictive score in order to identify recurrent thrombosis high risk patients
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Residual Platelet Activity In Advanced Peripheral Artery Disease
Official Title  ICMJE Tailored Strategy for Residual Platelet Activity In Advanced Peripheral Artery Disease: New Optimal Management.
Brief Summary

The peripheral arterial disease (PAD) is a common atherosclerotic disease manifestation and its prevalence increase with age and with the simultaneous presence of cardiovascular risk factors.

PAD patients are usually treated, as a first line treatment, with the exercise therapy, combined with the pharmacological antiplatelet therapy.

In the case of first line therapy failure, PAD patients usually undergoing to invasive revascularization procedures.

After a peripheral stent has been located, the major follow-up problem is the restenosis rate.

Published studies describe how, in a large amount of patients, can be recognised an high residual platelet activity. These data about PAD patients at the moment are lacking .

The authors would evaluate the incidence of PAD patients with an high residual platelet activity.

Detailed Description

The peripheral arterial disease (PAD) is a common atherosclerotic disease manifestation and its prevalence increases with age and with the co-presence of cardiovascular risk factors. PAD affects a large proportion of the adult population, with an age-adjusted prevalence of 4-15% which increases to 29% in case of comorbidity such as the presence of diabetes mellitus in the same individual. Less than 20% of patients with peripheral arterial laments the typical symptom of "claudication intermittens". Studies on the symptomatic PAD natural history indicate that the risk of limb loss in non-diabetic patients is low (2% or less), but the cardiovascular disease represent the leading cause of death; the annual rate of cardiovascular events (myocardial infarction, stroke or cardiovascular death) is between 5 and 7%. Medical treatment and / or surgery in this type of patient should be directed not only to improve the walking autonomy but also to reduce cardiovascular risk. Claudicant patients first-line therapy is based on structured physical exercise program and, in some specific cases, on the antiplatelet pharmacological therapy. The lack of response to exercise and / or drug therapy should lead to the next level of decision making, which is to consider limb revascularization procedures. However, in patients with suspected proximal lesion (gluteal claudication or absent femoral pulse), revascularization procedures could be considered as a first line therapy. When the revascularization procedures are considered, the first choice intervention should be the endovascular strategy, considering the lowest number of periprocedural complications. Recommendations for optimal drug therapy after revascularisation procedures in the lower limbs are hampered by lack of agreement on the optimal role of these procedures, and lack of data from randomized clinical trials. Transluminal angioplasty (PTA), primary or associated with stenting, is recommended for focal stenotic lesions of the iliac (common and external first section) and femoral-popliteal axis, particularly when the claudication intermittents is considered as severe, rather than critical ischemia. Also, this approach is recommended in non-diabetic patients with a relatively preserved tibial vessels flow. Exists a minor agreement about endovascular procedures use in extended occlusive lesions. In recent years, has become more common the use of open or covered stents during endovascular treatments in order to make it more secure and durable over time, especially in obstructive and extended lesions. This has certainly led to improved primary patency outcomes, but has entailed and still entails additional problems of drug therapy agreement.

Nowadays, the main problem concerning lower limbs revascularization is the post-procedure anti-thrombotic pharmacological treatment and the different antiplatelet drugs effectiveness This issue was addressed in two meta-analyses, where have been shown how the data are not conclusive. Moreover, a recent study by Marcucci et al (Circulation. 2009; 119: 237-42) has clearly shown that impaired platelet activation inhibition is a crucial point for the prevention of vascular outcomes, because residual platelet reactivity has been associated with adverse vascular outcomes.

Overall, these data identify two key issues:

  1. Platelet hyperactivation, usually observed after revascularization procedures;
  2. The platelet inhibition percentage appears crucial to reduce postoperative thrombotic complications and restenosis early onset.

Therefore, a unique aspect of this study is to analyze whether after peripheral revascularization procedures a platelet hyperactivation is observed and evaluate the possible involved mechanisms. In fact, the knowledge of the underlying mechanism could lead to more appropriate pharmacological approach to prevent platelet activation. In this context, the authors would explore the role of reactive oxygen species (ROS) in inducing platelet activation in patients with PAD undergoing revascularization devices.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE
  • Drug: Acetylsalicylic acid
    100 mg once per day
    Other Name: Aspirin
  • Drug: Clopidogrel
    75 mg once per day
    Other Name: Plavix
Study Arms  ICMJE Antiplatelet therapy
Patients underwent peripheral revascularization procedures undergoing a double antiplatelet therapy
Interventions:
  • Drug: Acetylsalicylic acid
  • Drug: Clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 20, 2012)
410
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2015
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Claudicatio Intermittens affected patients in which both exercise than pharmacological therapies failed
  • Ankle Brachial Index < 0.9 or > 1.3
  • Peripheral Arteries stenosis > 50% bilateral

Exclusion Criteria:

  • Acute Limb Ischemia patients
  • Patients that underwent a peripheral revascularization procedure within 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01627431
Other Study ID Numbers  ICMJE SAPIENZA-PAD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francesco Violi, University of Roma La Sapienza
Study Sponsor  ICMJE University of Roma La Sapienza
Collaborators  ICMJE University of Florence
Investigators  ICMJE
Study Chair: Francesco Violi, MD Divisione di Prima Clinica Medica - Sapienza University of Rome
Study Chair: Rosanna Abate, MD Azienda Ospedaliero-Universitaria Careggi University of Florence
PRS Account University of Roma La Sapienza
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP