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Residual Platelet Activity In Advanced Peripheral Artery Disease (TRAIANO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
University of Florence
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: Acetylsalicylic acid Drug: Clopidogrel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Tailored Strategy for Residual Platelet Activity In Advanced Peripheral Artery Disease: New Optimal Management.
Study Start Date : July 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Antiplatelet therapy
Patients underwent peripheral revascularization procedures undergoing a double antiplatelet therapy
Drug: Acetylsalicylic acid
100 mg once per day
Other Name: Aspirin

Drug: Clopidogrel
75 mg once per day
Other Name: Plavix

Primary Outcome Measures :
  1. Residual Platelet Activity [ Time Frame: 2 years ]
    Evaluate the high residual platelet activity prevalence in PAD patients

Secondary Outcome Measures :
  1. Target vessels thrombosis [ Time Frame: 2 years ]
    Evaluate the target vessels thrombosis incidence

  2. Major Cardiac Events [ Time Frame: 2 years ]
    Evaluate the Major Cardiac Events (MACE) incidence in PAD patients undergoing the peripheral revascularization procedures.

  3. Platelet aggregation tests [ Time Frame: 2 years ]
    Compare the different platelet aggregation tests specificity, sensitivity, accuracy and predictive values

  4. Oxidative stress [ Time Frame: 2 years ]
    Evaluate platelet activation and oxidative stress indexes relationship

  5. 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

  6. High risk patients score [ Time Frame: 2 years ]
    Validate a clinical-laboratoristic predictive score in order to identify recurrent thrombosis high risk patients

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01627431

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Contact: Francesco Violi, Prof +39-06-4461933
Contact: Stefania Basili, Prof +39-06-49974678

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University of Florence - Azienda Ospedaliero-Universitaria Careggi Not yet recruiting
Florence, Italy, 50134
Contact: Rosanna Abbate, MD    055 7949417 ext +39   
Principal Investigator: Rosanna Abbate, MD         
Sub-Investigator: Rossella Marcucci, MD         
Sapienza- University of Rome -Azienda Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Francesco Violi, MD    06 4461933 ext +39   
Contact: Stefania Basili, MD    06 49974678 ext +39   
Principal Investigator: Francesco Violi, MD         
Sub-Investigator: Stefania Basili, MD         
Sub-Investigator: Giulio Illuminati, MD         
Sub-Investigator: Bruno Gossetti, MD         
Sub-Investigator: Paolo di Marzo, MD         
Sub-Investigator: Francesco Speziale, MD         
Sub-Investigator: Antonella Marcoccia, MD         
Sponsors and Collaborators
University of Roma La Sapienza
University of Florence
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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
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Responsible Party: Francesco Violi, Prof., University of Roma La Sapienza Identifier: NCT01627431    
Other Study ID Numbers: SAPIENZA-PAD
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012
Keywords provided by Francesco Violi, University of Roma La Sapienza:
Peripheral revascularization
Antiplatelet therapy
Residual platelet activity
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents